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Product Sterility- Cleanroom Test

Product Sterility- Cleanroom Test

The Product Sterility – Cleanroom test is necessary for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms.

This test is performed according to the recommendations in USP General Chapter 71, ANSI/AAMI/ISO 11737-2, EP 2.6.1, JP <JP XV, 54> and 21 CFR 610.12. To optimize aseptic transfer of samples into the test media, all testing is performed in a state-of-the-art ISO Class 5 cleanroom. Sterility tests must be validated by performing a Method Suitability (Bacteriostasis/Fungistasis) test.

Applicable Standards

USP 71    |    USP 161    |    USP 797    |    EP 2.6.1    |    JP 14 54    |    ANSI/AAMI/ISO 1137    |    AAMI TIR 33

Pricing/Quote

Test Price Request Quote
BFS110 - Sterility B/F Validation: USP method (filtration)
Per test1+$685.00
Add
BFS120 - Sterility B/F Validation: USP method (standard)
Per test1+$450.00
Add
PSC110 - Product Sterility: Direct Transfer (Cleanroom), <1L volume
Per sample1+$16.50
Add
PSC120 - Product Sterility: Direct Transfer (Cleanroom), >1L volume
Per sample1+$35.00
Add
PSC150 - Product Sterility: Membrane Filtration (Cleanroom)
Per sample1+$35.00
Add
PSC220 - Product Sterility: Membrane Filtration, Sterile Pathway (Cleanroom)
Per sample1+$45.00
Add
PSC710 - Product Sterility: Cleanroom Session Fee
Per test1+$175.00
Add
PSC715 - Product Sterility: Media transfer fee, per unit
Per sample1+Quote
Add
PSC720 - Product Sterility: Daily reads for sterility test, per day
GeneralFee1+$15.00
Add
PSC830 - Product Sterility (Filtration System): < 2L PEPTflush, per filter
Per sample1+Quote
Add
PSC831 - Product Sterility (Filtration System): >2L PEPTflush, per filter
Per sample1+Quote
Add
BFS110 - Sterility B/F Validation: USP method (filtration)
Per test1+$685.00
BFS120 - Sterility B/F Validation: USP method (standard)
Per test1+$450.00
PSC110 - Product Sterility: Direct Transfer (Cleanroom), <1L volume
Per sample1+$16.50
PSC120 - Product Sterility: Direct Transfer (Cleanroom), >1L volume
Per sample1+$35.00
PSC150 - Product Sterility: Membrane Filtration (Cleanroom)
Per sample1+$35.00
PSC220 - Product Sterility: Membrane Filtration, Sterile Pathway (Cleanroom)
Per sample1+$45.00
PSC710 - Product Sterility: Cleanroom Session Fee
Per test1+$175.00
PSC715 - Product Sterility: Media transfer fee, per unit
Per sample1+Quote
PSC720 - Product Sterility: Daily reads for sterility test, per day
GeneralFee1+$15.00
PSC830 - Product Sterility (Filtration System): < 2L PEPTflush, per filter
Per sample1+Quote
PSC831 - Product Sterility (Filtration System): >2L PEPTflush, per filter
Per sample1+Quote

Turn Around Time

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT
BFS110 Sterility B/F Validation: USP method (filtration) 10
BFS120 Sterility B/F Validation: USP method (standard) 10
PSC110 Product Sterility: Direct Transfer (Cleanroom), <1L volume Product and media dependent
PSC120 Product Sterility: Direct Transfer (Cleanroom), >1L volume Product and media dependent
PSC150 Product Sterility: Membrane Filtration (Cleanroom) Product and media dependent
PSC220 Product Sterility: Membrane Filtration, Sterile Pathway (Cleanroom) Product and media dependent
PSC710 Product Sterility: Cleanroom Session Fee Product and media dependent
PSC830 Product Sterility (Filtration System): < 2L PEPTflush, per filter Product and media dependent
PSC831 Product Sterility (Filtration System): >2L PEPTflush, per filter Product and media dependent
Code TAT
BFS110 10
BFS120 10
PSC110 Product and media dependent
PSC120 Product and media dependent
PSC150 Product and media dependent
PSC220 Product and media dependent
PSC710 Product and media dependent
PSC830 Product and media dependent
PSC831 Product and media dependent

Sample Specifications

BFS110: 6 samples
BFS120: 6 samples
PSC110: Dependent on product or test method (USP/AAMI/ISO)
PSC830: Per filter
PSC831: Per filter

Study Outline

The Product Sterility – Cleanroom test evaluates samples for sterility by placing them in growth media, incubating them for a minimum of 14 days and then checking for evidence of microbial contamination.
Samples may be tested using either direct transfer or membrane filtration, and using a soybean casein digest broth (soy) or fluid thioglycollate (thio) media, as follows:

USP Method: Samples tested by direct transfer are aseptically immersed in the test media. Samples tested by membrane filtration (liquids, filterable solids, soluble ointments [oils] and sterile-pathway-only devices) are passed through a 0.45µm filter, and the filter is immersed in the test media. A soybean casein digest broth (soy) media is used for aerobic and fungal growth at incubation temperatures of 20 – 25°C or 28 – 32°C. A fluid thioglycollate (thio) media is used for anaerobic growth at an incubation temperature of 30 – 35°C. Sample size is determined both by batch size and individual container fill volumes.

AAMI Method: Samples tested by direct transfer are aseptically immersed in the test media. Soy is used for aerobic and fungal growth at incubation temperatures of 20 – 25°C or 28 – 32°C. Sample size depends on lot size, method used and bioburden levels.

After a 14-day incubation, samples are evaluated for the presence of turbidity and/or growth. A media transfer and/or confirmation test may be performed. A failure investigation is performed as necessary.  Recovered organisms are identified and compared to the organisms that may have been recovered on monitors performed by the test analyst during applicable test sessions. It is determined whether any anomalies occurred on day of testing, with media sterilization, during sample processing and/or during shipping.