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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 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 (B/F), Sterility and MPN Method Suitability) test.

Applicable Standards

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

Test Options

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

Code Test TAT (days) Request Quote
BFS110 Sterility B/F Validation: USP method (filtration) 10 Add
BFS120 Sterility B/F Validation: USP method (standard) 10 Add
PSC110 Product Sterility: Direct Transfer (Cleanroom), <1L volume, USP Add
PSC115 Product Sterility: Direct Transfer (Cleanroom), <1L volume, AAMI Add
PSC120 Product Sterility: Direct Transfer (Cleanroom), >1L volume, USP Add
PSC125 Product Sterility: Direct Transfer (Cleanroom), >1L volume, AAMI Add
PSC150 Product Sterility: Open Membrane Filtration (Cleanroom), USP Add
PSC155 Product Sterility: Closed Membrane Filtration (Cleanrooom), USP Add
PSC156 Product Sterility: Closed Membrane Filtration (Cleanroom) - Canister Fee, USP Add
PSC220 Product Sterility: Membrane Filtration, Sterile Pathway (Cleanroom) Add
PSC710 Product Sterility: Cleanroom Session Fee Add
PSC715 Product Sterility: Media transfer fee, per unit Add
PSC720 Product Sterility: Daily reads for sterility test, per day Add
PSC745 Product Sterility: Additional Technician for Manipulation of Kits Add
PSC830 Product Sterility (Filtration System): < 2L PEPTflush, per filter Add
PSC831 Product Sterility (Filtration System): >2L PEPTflush, per filter Add
BFS110 - Sterility B/F Validation: USP method (filtration)
10 days
BFS120 - Sterility B/F Validation: USP method (standard)
10 days
PSC110 - Product Sterility: Direct Transfer (Cleanroom), <1L volume, USP
Standard TAT not available for this product
PSC115 - Product Sterility: Direct Transfer (Cleanroom), <1L volume, AAMI
Standard TAT not available for this product
PSC120 - Product Sterility: Direct Transfer (Cleanroom), >1L volume, USP
Standard TAT not available for this product
PSC125 - Product Sterility: Direct Transfer (Cleanroom), >1L volume, AAMI
Standard TAT not available for this product
PSC150 - Product Sterility: Open Membrane Filtration (Cleanroom), USP
Standard TAT not available for this product
PSC155 - Product Sterility: Closed Membrane Filtration (Cleanrooom), USP
Standard TAT not available for this product
PSC156 - Product Sterility: Closed Membrane Filtration (Cleanroom) - Canister Fee, USP
Standard TAT not available for this product
PSC220 - Product Sterility: Membrane Filtration, Sterile Pathway (Cleanroom)
Standard TAT not available for this product
PSC710 - Product Sterility: Cleanroom Session Fee
Standard TAT not available for this product
PSC715 - Product Sterility: Media transfer fee, per unit
Standard TAT not available for this product
PSC720 - Product Sterility: Daily reads for sterility test, per day
Standard TAT not available for this product
PSC745 - Product Sterility: Additional Technician for Manipulation of Kits
Standard TAT not available for this product
PSC830 - Product Sterility (Filtration System): < 2L PEPTflush, per filter
Standard TAT not available for this product
PSC831 - Product Sterility (Filtration System): >2L PEPTflush, per filter
Standard TAT not available for this product

Sample Specifications

BFS110: 6 samples
BFS120: 6 samples
PSC110: Turn Around Time is product and media dependent. Sample specifications are dependent on product or test method (USP/AAMI/ISO)
PSC115: Turn Around Time is product and media dependent. Sample specifications are dependent on product or test method (USP/AAMI/ISO)
PSC120: Turn Around Time is product and media dependent
PSC125: Turn Around Time is product and media dependent
PSC150: Turn Around Time is product and media dependent
PSC155: Turn Around Time is product and media dependent
PSC220: Turn Around Time is product and media dependent
PSC710: Turn Around Time is product and media dependent
PSC720: Sponsor will be contacted if preliminary growth is observed during the daily reads
PSC830: Turn Around Time is product and media dependent. Sample Specification is per filter
PSC831: Turn Around Time is product and media dependent. Sample Specifications is 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.