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Product Sterility- Isolator Test

Product Sterility- Isolator Test

The Product Sterility – Isolator test protects test articles from contamination by eliminating direct contact between the analyst and the test articles. This test is required on medical devices, pharmaceuticals, preparations, tissue materials and any other materials that claim to be sterile or free from viable microorganisms.

Testing is done in conformance with criteria from 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 test material, sterility testing is performed in a state-of-the-art isolator. Vaporized hydrogen peroxide is used to sterilize the contents of the isolator and the inside of the enclosure prior to testing. Isolator sterility tests must be validated by performing a Method Suitability study (Bacteriostasis/Fungistasis (B/F), Sterility and MPN Method Suitability) test. Isolator sterility tests must also have isolator package validation testing performed.

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. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
BFS130 Sterility B/F Validation: Isolator 12 Add
PSI110 Product Sterility: Direct Transfer Method (Isolator) 21 Add
PSI150 Product Sterility: Membrane Filtration (Isolator) 21 Add
PSI156 Product Sterility: Membrane Filtration (Isolator), Canister fee Add
PSI701 Product Sterility: Packaging Validation for Isolator Sterility Tests 7 Add
PSI710 Product Sterility: Isolator Session Fee Add
BFS130 - Sterility B/F Validation: Isolator
TAT: 12 days
PSI110 - Product Sterility: Direct Transfer Method (Isolator)
TAT: 21 days
PSI150 - Product Sterility: Membrane Filtration (Isolator)
TAT: 21 days
PSI156 - Product Sterility: Membrane Filtration (Isolator), Canister fee
Standard TAT not available for this product
PSI701 - Product Sterility: Packaging Validation for Isolator Sterility Tests
TAT: 7 days
PSI710 - Product Sterility: Isolator Session Fee
Standard TAT not available for this product

Sample Specifications

BFS130: 6 samples
PSI110: Turn Around Time is product and media dependent
PSI150: Turn Around Time (TAT) may be product and media dependent. TAT listed is based on standard medias and volumes.
PSI701: Turn Around Time is product and media dependent. Sample Specifications is a minimum of 5 samples

Study Outline

The Product Sterility – Isolator 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. This sterility test is performed in an isolator that has been sterilized with vaporized hydrogen peroxide.
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.

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