TRIO.BAS Accessories

GLP EASY RACK AISI 316 Contact - capacity up 15 Contact plate 55mm. size: diam. 110x215h mm. - weight 285 gr.

Cleanroom Stainless Steel Rack with handle for stacking, storing, and transporting culture plates (Petri or Contact plate). They are used to maintain the distance inside the incubator according the GLP* (Good Laboratory Practice).

DETAILS

• They can be refrigerated, incubated and autoclaved
• Each rack can hold up to 11 Petri dishes, or 15 Contact plates
• A wide front opening permits easy access but prevents dishes from sliding out
• The same rack can be adjusted for Petri or Contact plate
• Avoids all risk of accident during loading and transport to the incubator for staff bio-hazard safety
• The weight of only 280 gr. make it light and easy to carry
• The small size allows to maximize the space inside the incubator
• Racks are fully autoclavable

*ISO Standard and GPL request that inside the incubator the culture plates are stacked not more than six and at a distance of 2 cm.

GLP EASY RACK AISI 316 Petri - capacity up 11 Petri dish 90 mm. size: diam. 110x215h mm. - weight 285 gr.

Cleanroom Stainless Steel Rack with handle for stacking, storing, and transporting culture plates (Petri or Contact plate). They are used to maintain the distance inside the incubator according the GLP* (Good Laboratory Practice).

DETAILS

• They can be refrigerated, incubated and autoclaved
• Each rack can hold up to 11 Petri dishes, or 15 Contact plates
• A wide front opening permits easy access but prevents dishes from sliding out
• The same rack can be adjusted for Petri or Contact plate
• Avoids all risk of accident during loading and transport to the incubator for staff bio-hazard safety
• The weight of only 280 gr. make it light and easy to carry
• The small size allows to maximize the space inside the incubator
• Racks are fully autoclavable

*ISO Standard and GPL request that inside the incubator the culture plates are stacked not more than six and at a distance of 2 cm.

IN-REST holder - Stainless steel AISI 316 - size 90x120x105H mm - weight 127 gr.

Operators, and their activities, represent the greatest risk of contamination inside cleanrooms. Operators must work under stringent conditions; required to wear special overalls, gloves, facemasks, and eye masks. For these reasons, it is advisable to create the best possible working conditions. Air sampling with microbiological samplers is a complex and delicate operation, whether using an instrument with a single aspirating head, or an instrument with more than one aspirating head. To facilitate operations and avoid errors and risks of contamination during the sampling phase, the TRIO.BAS IN-REST is particularly useful as a temporary support for culture media plates and/or lids, and instrument sampling heads.

FEATURES

• Built in AISI 316 stainless steel
• Wedge shape inclined at 150°
• Two-sided Support
• Usable for Petri dishes, Contact plates and aspirating heads
• A single hole on one side, and two holes on the other side, facilitate identification of plates and heads

For remote system.

Remote Stainless Steel Tri Clamp Aspirating Funnel System

• This sampling system is completely fabricated in AISI 316 rated stainless steel
• The TRI CLAMP connection simplifies all the cleaning/sterilization operations
• The risk of contamination associated with operator activities is reduced

(*) different sizes on request

Inkluderar TB261, TB331, TB465, TB265, TB397

TRIO.CPS (TRIO kontaktprovtagare)

• TRIO.CPS (Kontaktprovtagare) hjälper till att standardisera ytövervakningen med traditionella kontaktplattor

• TRIO.CPS används med en kontaktplatta (t.ex. RODAC) diameter 55 mm. Tio sekunders timer garanterar att uppfylla ISO 18593 för horisontell ytprovtagning.

• Resultaten blir jämförbara med olika operatörer.

• Metallbotten medför en desinfektion/sterilisering.

• CFU räknas vid slutet av inkubationen och resultaten rapporteras som CFU / cm2 eller CFU / platta.

TEKNISK SPECIFIKATION

Timer: 10 sekunder

Arbetstemperatur: 0-40 ° C

Mått: 10x3 cm

Location Barcode TAG - Size 85x55 mm - 10 per box, used to personalize the location where the sampling is made.

User Barcode TAG - Size 85x55 mm - 10 per box,  used to personalize the operators working with microbiological air sampler.

BAS Software license - transfer data from instrument or smartphone/tablet to PC by Bluetooth.

This software is compliant with CFR 21 Part 11 Data Integrity. It manages the sampling data transfer from the air sampler to the PC. It also facilitates the configuration of users and places on the air sampler.

Android APP “BAS” för att överföra data till Smartphone / surfplatta och sedan via kabel till PC (alternativ till programvara för nedladdning av data)

PORTABLE COMMAND UNIT CPU - 10”

This device comes with already installed APP Android ASAPP.

The CPU Portable Command Unit is an ideal instrument to simplify and to facilitate the activity of operator.

The Bluetooth connection with all TRIO.BAS™ instruments allows to download the sampling data.

The PCU can also be used to control the switch on, switch off and pause of the air sampler remotely.

The data downloaded from the instruments through the CPU, can be transferred to a PC where Air Sampler ASPC software (code 295) or BAS software (code 296) is installed (i.e. by USB connection).

APP Android "BASAPP" - transfer data from instrument to smartphone/tablet by Bluetooth.

• Batterierna laddas när provtagaren är i viloläge
• Ingen laddningssladd krävs för instrument
• Luftprovtagaren är fri från externa kontakter
• Basstationens induktionsbatteriladdare kan bytas ut mot SELFTEST SYSTEM för att verifiera korrekt flödeshastighet med jämna mellanrum
• USB-uttag för anslutning och laddning av andra externa enheter (Bluetooth-skrivare, smartphone, streckkodsläsare etc.)
• IP65-damm- och vattentät certifiering
• ISO 9001 överensstämmer

Metallhuvudet är tillverkat i polerat AISI 316 rostfritt stål. De är individuellt testade och har ett identifieringsnummer enligt GLP och GMP.

• Har en lätt vikt vilket bidrar till en enkel hantering av luftprovtagaren.

• Med bajonettfattning är det enkelt att sätta på metallhuvudet på luftprovtagaren utan onödiga rörelser.

• Huvudet har 221 kalibrerade hål - 1 mm diameter.

• För varje luftprovtagningscykel, eller provtagningar i samma kontrollerade miljö, används ett steriliserat huvud.

• Varje metallhuvud bör steriliseras genom autoklavering.

Metallhuvudet är tillverkat i polerat AISI 316 rostfritt stål. De är individuellt testade och har ett identifieringsnummer enligt GLP och GMP.

• Har en lätt vikt vilket bidrar till en enkel hantering av luftprovtagaren.

• Med bajonettfattning är det enkelt att sätta på metallhuvudet på luftprovtagaren utan onödiga rörelser.

• Huvudet har 221 kalibrerade hål - 1 mm diameter.

• För varje luftprovtagningscykel, eller provtagningar i samma kontrollerade miljö, används ett steriliserat huvud.

• Varje metallhuvud bör steriliseras genom autoklavering.

Polykarbonathuvudet kan autoklaveras 5 gånger (t.ex. i 115 eller 121 ° C i 30 minuter.)

Användning av "Daily Shift" Head (DSH) medför tidsbesparing genom att slippa autoklaveringsprocessen in house.

• Certifikat för steriliseringsprocessen medföljer.

• ”Daily shift” huvudet är dubbelförpackat.

• Särskilt användbart vid autoklavstrul eller vid hög provtagningsaktivitet.

• “Daily Shift” -huvudet är genomskinligt för att visualisera att provtagningsplatta är insatt i luftprovtagaren.

• Återvinningsbar plast.

Användning av "Daily Shift" Head (DSH) medför tidsbesparing genom att slippa autoklaveringsprocessen in house.

• Certifikat för steriliseringsprocessen medföljer.

• ”Daily shift” huvudet är dubbelförpackat.

• Särskilt användbart vid autoklavstrul eller vid hög provtagningsaktivitet.

• “Daily Shift” -huvudet är genomskinligt för att visualisera att provtagningsplatta är insatt i luftprovtagaren.

• Återvinningsbar plast.

COVER BACT for plate - polystyrene – to cover the plate after sampling –sterile packaged

Stängt System;

Sterilt Polystyrenhuvud + Tryptone- soja- agarplatta i ett.  (10st/box)

Stängt System;

Sterilt polystyrenhuvud + Sabouraud agarplatta i ett. (10 st/ box)

SELFTEST är ett system som kontrollerar luftflödeshastigheten. Denna kontroll är viktig för att undvika ogiltigförklaring av testerna mellan de årliga kontrollerna.

Användbart till luftprovtagare som används inom läkemedelstillverkning, renrum och bioteknikindustrin som följer GMP/GLP.

Basstationen sörjer även för laddning av TRIO.BAS luftprovtagarens batterier.

SELFTEST fungerar endast för luftprovtagare med induktionsladdare.

Systemets funktion bygger på en mätning det tryck som generas när luftprovtagaren suger in luft genom ett speciallock (klocka) och en differenstrycksensor jämför det med det inställda värdet som lagrats i Trio.Bas-provtagaren vid den externa kalibreringen. Resultatet visas på LDC skärmen på luftprovtagaren antingen som OK (luftprovtagen är kalibrerad) eller som VARNING/FEL (luftprovtagen skiljer från det kalibrerade värdet)

Resultatet registreras automatiskt i luftprovtagaren.

ISO 9001 överensstämmer

En basstation inklusive induktionsbatteriladdare med Selftest kalibreringssystem.

(200 l / min) 90 mm platta eller 55 mm kontaktplatta - Kabel med kontaktanslutning Standard Schuko - Denna basstation används som ersättning för basstationen kat. 310 när Selftest-systemet används)

Basstationens induktionsbatteriladdare med User Selftest är utrustad med ett system som tillåter, oavsett vilken auto-kalibrering som redan finns i instrumentet, att kunna kontrollera luftflödet. Denna verifiering är nödvändig för att undvika ogiltigförklaring av testerna mellan årliga kontroller för officiell certifiering.

VERITEST - check calibration system (100-200 lt/min)- command unit with digital display and techno-polymer bell.- size 125x93x95H mm.- light carrying case

The VERITEST is a system that, instead of the auto calibration already present in the air sampler, checks the precision of the air flow rate. This check is necessary to avoid invalidation of the tests between annual controls for official certification.

Main customers are GLP/GMP for pharmaceutical, cleanrooms and biotech industries.

The VERITEST is a manual system thus the results need to be reported in a document validated by a quality controller.

VERITEST is suitable for all air samplers and satellites.

s/s TRIO.SETTLE table plate stand – size: diam 12 x 20H cm.

Passive sampling, combined with active sampling, is recognized by regulatory organizations as useful in assessing the microbial quality of the air environment.

The settle method is applied with the culture plate in a horizontal or inclined position, according to the direction of the unidirectional air flow. In a horizontal position, air flow may be obstructed creating a slight turbulence over the surface of agar which could deviate the viable particles from the agar’s surface.

A slanted position of the Petri dish allows the air to hit the agar surface and pass by without disturbance. TRIO.SETTLE is an articulate device developed to standardize, test, and enumerate the presence of microorganisms when applying the passive air monitoring, or settling plate, method.

Passive air sampling provides a quantitative analysis of airborne microorganisms deposited onto the surface of an agar plate over a period of exposure.

TRIO.SETTLE can be fixed on a tripod or other floor support devices. TRIO.SETTLE is fabricated from AISI 316 stainless steel and fully autoclavable.

Validated according to “EN 17141”.

s/s TRIO.SETTLE floor plate stand – size: base diam. 25 x 110H cm.

Passive sampling, combined with active sampling, is recognized by regulatory organizations as useful in assessing the microbial quality of the air environment.

The settle method is applied with the culture plate in a horizontal or inclined position, according to the direction of the unidirectional air flow. In a horizontal position, air flow may be obstructed creating a slight turbulence over the surface of agar which could deviate the viable particles from the agar’s surface.

A slanted position of the Petri dish allows the air to hit the agar surface and pass by without disturbance. TRIO.SETTLE is an articulate device developed to standardize, test, and enumerate the presence of microorganisms when applying the passive air monitoring, or settling plate, method.

Passive air sampling provides a quantitative analysis of airborne microorganisms deposited onto the surface of an agar plate over a period of exposure.

TRIO.SETTLE can be fixed on a tripod or other floor support devices. TRIO.SETTLE is fabricated from AISI 316 stainless steel and fully autoclavable.

Validated according to “EN 17141”.

This cart is suitable mostly for cleanrooms. Adjustable height from 100 cm to 210 cm A fixed vertical hook and a vertical extensible support with ball joint are included with the cart It is robust and is easily used with an air sampler fixed on it.

It is equipped with 2 shelves. It is suitable for sampling at a medium height from the floor. Optional: stand up holder for TRIO.BAS MINI (code 370), stand up holder for TRIO.BAS MONO, DUO, TRIO (code 376) or stand up holder for AIRBIO (code 377).

MAXI MULTI HOLDER cart on wheels - stainless steel AISI 314 and 316 - size 500x400x850H mm - weight 7 kg

STAND UP MAXI HOLDER FOR MONO, DUO, TRIO

Completely made in high density impact resistant techno-polymer. The shaped base allows the vertical positioning of the air sampler with the use of just one hand.

They can be positioned in any work surface or on all tripods and MINI multi holder chart with wheels. The stand up fixed on vertical tripod lets the air sampler be independent from the vertical tripod for charging the battery or removing the plates for sampling, facilitating the handling operations.

STAND UP MAXI holder - techno-polymer high density - size 165x105x785H mm - weight 256 gr.

The air sampler can be fixed directly on the tripod or alternatively on a STAND UP (optional) for TRIO.BAS MINI (code 370), stand up holder for TRIO.BAS MONO, DUO, TRIO (code 376) or stand up holder for AIRBIO (code 377).This solution facilitates the operator's activity as the sampler can be inserted and removed from the tripod with one hand and without the constraint of screwing or unscrewing the instrument.

For fixing MULTIFLEX Instruments to the s/s Tripod (code 523) or s/s Maxi Multi cart (code 372).

Ideal for placement of MULTIFLEX at various heights and cleanroom points that are not easily accessible.

Simple, stable design: The MULTIFLEX instrument easily attaches to the Holder without fixing screws.

MULTIFLEX HOLDER - stainless steel AISI 316 - size 250x140 mm

Transportable and compact, the MAXI TRIPOD is an innovative floor tripod. Made from light weight aluminum.

• It is particularly useful for sampling with TRIO.BAS air sampler at medium and high height from the floor
• Adjustable height from min.125 cm to max 366 cm
• The air sampler can be fixed directly on the tripod or alternatively on a STAND UP holder (optional) fixed on the tripod. This solution facilitates the operator's activity as the sampler can be inserted and removed from the tripod with one hand and without the constraint of screwing or unscrewing the instrument
• Compact 4 section stand with 3 risers
• Smooth cushioning of tube movement when the tripod is raised or lowered protects your fingers
• The wide bases opens up to 107cm to keep the tripod steady

MAXI FLOOR TRIPOD - light weight anodized aluminium - Size tripod close 140x80x1100H mm - weight 2.5 kg.

This adapter fixed to the air sampler or to the STAND UP and inserted on the shaft of the TRIPODs or the MAXI CART allows the instrument to be positioned at different angles.

Central ball head (optional for MAXI FLOOR TRIPOD)

ROBUSTUS LARGE MM carrying case for TRIO.BAS MULTIFLEX 1+2/TRIO.BAS MULTISTATION with 1-3 Satellites - Size 560x430x220H mm - weight 5,6 kg.

These Carrying cases have very performing characteristics. This allows the instruments to be safely contained both for transport by customers when they have to carry out tests in different environments. They are also indispensable when they must be sent to accredited assistance centers to carry out repairs or calibration - Easy to open double throw latches - foam inlays to protect the instrument.

Made in polypropylene copolymer - Thick body material - range temperature -30° /+90° C - are watertight to offer protection from water ( IP67), dust and impact. No problem for airplane transport (ATA300).

ROBUSTUS LARGE G carrying case for TRIO.GAS - size 560x430x310H mm - weight 5,6 kg.

These Carrying cases have very performing characteristics. This allows the instruments to be safely contained both for transport by customers when they have to carry out tests in different environments. They are also indispensable when they must be sent to accredited assistance centers to carry out repairs or calibration - Easy to open double throw latches - foam inlays to protect the instrument.

Made in polypropylene copolymer - Thick body material - range temperature -30° /+90° C - are watertight to offer protection from water ( IP67), dust and impact. No problem for airplane transport (ATA300).

ROBUSTUS MEDIUM A carrying case for AIRBIO - size 560x430x220H mm - weight 4,6 kg.

These Carrying cases have very performing characteristics. This allows the instruments to be safely contained both for transport by customers when they have to carry out tests in different environments. They are also indispensable when they must be sent to accredited assistance centers to carry out repairs or calibration - Easy to open double throw latches - foam inlays to protect the instrument.

Made in polypropylene copolymer - Thick body material - range temperature -30° /+90° C - are watertight to offer protection from water ( IP67), dust and impact. No problem for airplane transport (ATA300).

LIGHT STANDARD carrying case for VERITEST - size 430x350x190H mm - weight 1,3 kg.

These Carrying cases have very performing characteristics. This allows the instruments to be safely contained both for transport by customers when they have to carry out tests in different environments.

They are also indispensable when they must be sent to accredited assistance centers to carry out repairs or calibration - Easy to open double throw latches - foam inlays to protect the instrument.

Made in polypropylene copolymer - Thick body material.

PRONTO SELF-SEALING STERILIZATION BAG FOR ASPI HEAD - Pre-folding ease the closing of the bags correctly. printed with steam indicators to confirm the correct sterilization - double bags kit - 190x300 / 240x400 mm.

These bags are particularly useful for autoclaving stainless steel or thermo-polymer ASPI HEAD. The kit consists of a double bag to be inserted in the autoclave with the head and guarantee sterility when it is brought inside the cleanroom.

They are used as replacement of the aluminum foil.

Rool paper for bluetooth printer: The ROLL PAPER is no erasable thermal paper. The paper is printed thermally but it keeps the ink during the time.

ROLL PAPER standard - Size 57 mm - 10 per box.

• Each microbial air sampling cycle, or group of sampling in the same controlled environment, with an active air sampler, requires the use of a sterile aspiration head
• Stainless steel aspiration heads should be sterilized by autoclaving and a sterilization document must be filled in, as requested by regulatory inspectors
• The process of sterilization can be avoided by adopting sterile “Daily Shift” antistatic resin plastic heads that are double packed and complete with official certificates of sterilization by irradiation

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

IQ, OQ, PQ DOCUMENTS

IQ installation qualification; OQ operational qualification; PQ performance qualification

In the pharmaceutical industry, accurate measurements are vital. Even slight errors can result in dangerous and potentially deadly consequences. This is why reliable equipment validation is so critical in the pharmaceutical industry. IQ OQ PQ represents a way to help ensure reliable performance for equipment for pharmaceutical industry purposes.

IQ, OQ and PQ stand for installation qualification, operational qualification and performance qualification, respectively. They represent quality assurance protocols for each phase of the manufacturing process for pharmaceutical equipment. Since the pharmaceutical industry is heavily regulated by the FDA, it is essential to follow IQ, OQ and PQ protocols.

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

METHOD

Read the pages of the document

ACCEPTANCE CRITERIA

Each pages of this document is based on a specific criterion that should be followed

HOW TO USE THE DOCUMENT

These Documents have the target to verify that the instrument is working according to the supplier specification, during the installation and during the working activities.

• Do the actions described in the pages of this Document
• Answer YES or NO to the questions present in each page
• Insert comments and corrective actions where they are applicable
• Date and sign each page when it has been completed
• Record the results each time a page of the Document has been completed
• Sign, date and register the document once it is fully completed

VERTIKALHÅLLARE

- i rostfritt stål - för bord, vagn, golvstativ - anpassningsbar till MINI, MONO, DUO, TRIO - storlek 12x15x25h cm.

(Glöm inte TB522 SKRUV i rostfritt stål för vertikalhållare TB521 och vägg / bordshållare TB530)

Skruv i rostfritt stål för vertikalhållare TB521 och vägg / bordshållare TB530

GOLVSTATIV - i rostfritt stål (teleskop, minst 150 cm - max 200 cm).

LIGHT STANDARD carrying case for TRIO.BAS MINI - size 430x350x190H mm - weight 1,3 kg.

These Carrying cases have very performing characteristics. This allows the instruments to be safely contained both for transport by customers when they have to carry out tests in different environments.

They are also indispensable when they must be sent to accredited assistance centers to carry out repairs or calibration - Easy to open double throw latches - foam inlays to protect the instrument.

Made in polypropylene copolymer - Thick body material.

VÄGG / BORDHÅLLARE – i rostfritt stål - anpassningsbar till MINI, MONO, DUO, TRIO -

2x13x16 h cm.

(Glöm inte TB522: SKRUV i rostfritt stål för vertikal hållare TB521 och vägg / bordshållare TB530)

It is a microbiological sampler to test the quality of compressed air/Nitrogen/CO2 or other gas in cleanroom

A complete instrument for all the microbial environmental monitoring needes test

AIR SAMPLER - GAS SAMPLER - CHECK OF FLOW RATE

AIR SAMPLER GAS SAMPLER CHECK OF FLOW RATE:

AGC air sampler consists of one instrument to sample air at 100 l/m.

The aluminum bell placed on the aspirating head allows to sample gas at 100 l/m.

The technopolymer yellow bell is used to check the precision of the instrument’s flow rate.

The body of the AGC instrument is designed to stand much more stable on the surface. It is also easier for the end user to read the keyboard and, as the aspirating head is vertical, to place the plates or the bell on it. Primary applications are for pharmaceutical aseptic filling suites, cleanrooms, biotech, IVF clinics, operating theaters, hospital, pharmacies, blood banks.

It is used for active microbial air sampling.

If used for sampling the gas, the instrument works by measuring the pressure’s variation generated by air sampler while air is aspirated through an aluminum bell. A differential pressure sensor measures that variation and compares it with the reference values.

The digital control unit works as a flow meter before the gas passes through the microbial sampler.

When used to check the status of the calibration, the instrument runs by measuring the pressure’s variation generated by air sampler while air is aspirated through a technopolymer bell placed on the head of the sampler. The differential pressure sensor measures that variation and compares it with the reference values.

At the end of the test, the instrument gives the result of the test: OK if the air sampler is still calibrated, WARNING or ERROR if the air sampler is not calibrated within initial calibration specifics.

• The data can be always transferred to a PC if a dedicated software is installed.
• The transfer data can be made via Bluetooth or via cable.
• The battery is recharged by a power cable connected directly to the air sampler.
• It is possible to work either in manual or automatic mode.
• When used as active air sampler the use of optional sterile “Daily Shift” aspirating heads reduces the risk of contamination.
• It is compact and easy to transfer.
• SOP (Standard Operating Procedure) available from Application Notes.

(*) each pack consists of: 1 air sampler with Bluetooth and power battery charger with 1 s/s aspiration head and 1 s/s cover head, 1 compact stainless steel bell chamber with a valve and a regulator for gas pressure, 1 technopolymer bell for calibration check, 1 autoclavable tube for connecting the control unit to the bell, 1 calibration certificate, 1 cable for data transfer, 1 robustus carrying case

A complete instrument for all the microbial environmental monitoring needes test

AIR SAMPLER - GAS SAMPLER - CHECK OF FLOW RATE

AIR SAMPLER GAS SAMPLER CHECK OF FLOW RATE:

AGC air sampler consists of one instrument to sample air at 100 l/m.

The aluminum bell placed on the aspirating head allows to sample gas at 100 l/m.

The technopolymer yellow bell is used to check the precision of the instrument’s flow rate.

The body of the AGC instrument is designed to stand much more stable on the surface. It is also easier for the end user to read the keyboard and, as the aspirating head is vertical, to place the plates or the bell on it. Primary applications are for pharmaceutical aseptic filling suites, cleanrooms, biotech, IVF clinics, operating theaters, hospital, pharmacies, blood banks.

It is used for active microbial air sampling.

If used for sampling the gas, the instrument works by measuring the pressure’s variation generated by air sampler while air is aspirated through an aluminum bell. A differential pressure sensor measures that variation and compares it with the reference values.

The digital control unit works as a flow meter before the gas passes through the microbial sampler.

When used to check the status of the calibration, the instrument runs by measuring the pressure’s variation generated by air sampler while air is aspirated through a technopolymer bell placed on the head of the sampler. The differential pressure sensor measures that variation and compares it with the reference values.

At the end of the test, the instrument gives the result of the test: OK if the air sampler is still calibrated, WARNING or ERROR if the air sampler is not calibrated within initial calibration specifics.

• The data can be always transferred to a PC if a dedicated software is installed.
• The transfer data can be made via Bluetooth or via cable.
• The battery is recharged by a power cable connected directly to the air sampler.
• It is possible to work either in manual or automatic mode.
• When used as active air sampler the use of optional sterile “Daily Shift” aspirating heads reduces the risk of contamination.
• It is compact and easy to transfer.
• SOP (Standard Operating Procedure) available from Application Notes.

(*) each pack consists of: 1 air sampler with Bluetooth and power battery charger with 1 s/s aspiration head and 1 s/s cover head, 1 compact stainless steel bell chamber with a valve and a regulator for gas pressure, 1 technopolymer bell for calibration check, 1 autoclavable tube for connecting the control unit to the bell, 1 calibration certificate, 1 cable for data transfer, 1 robustus carrying case

SATELLITE UNIT for CONTINUOUS MONITORING:

851K CONTINUOUS SATELLITE UNIT Petri PACK