Sterility Testing
Sterilization is any process that kills or deactivates microorganisms from a product. Sterilization validation is a critical test that supports manufacturers in confirming that their sterilization process repeatably delivers the required sterility assurance level for their product. A sterilization validation will need to be performed for each product type a manufacturer wishes to bring to market.
Our Tests
Direct Transfer / Product Immersion
M100
Up to 50ml volume of media per vessel/tube, each
M100A
100 to 250ml vessel, each
M100B
300 to 500ml vessel, each
M100C
600 to 1000ml vessel, each
M100D
Above 1000ml vessel, each
Biological Indicator (BI)
M102
Spore strip immersion in 15ml TSB, each
M102A
Self-contained BI test indicators, each
Fluid Pathway
M200
For volumes up to 100ml product flush – devices, each
Membrane Filtration
M300
USP, 20 devices, fluid pathway up to 100ml
M301
Individual devices, up to 100ml fluid pathway – each additional fluid pathway flush, each
M302
Individual sample
Device Verification Dose (AAMI - VDmax Method - 10 Product Dose Audit)
M450
Up to 50ml volume of media per vessel/tube
M450A
100 to 250ml vessel
M450B
300 to 500ml vessel
M450C
600 to 1000ml vessel
M450X
Continuation/Confirmation test on additional 10 samples
ANSI/
AAMI/
ISO
Radiation sterilization validation program – complete with bioburden validation, overall average lot determination and dose setting with sterility testing
Methods Suitability Test (formerly known as Bacteriostasis and fungistasis test) is required by the U.S. Pharmacopeia as a means of validating the Sterility Test. This essential step should be conducted on all new products or materials initially submitted for testing and should be repeated periodically to assure continued compatibility with established testing procedures.
Sample Submission
Purchase Order
In line with current ISO/QSR purchasing requirements, all orders should be sent with a signed completed Purchase Order. This will help expedite the processing or your order. Standing Purchase Orders will be gladly accepted for routine continuing orders.
Sample Submission Form
Please download and fill out a Test Request Form for each sample/test submitted. Identify each submission clearly and completely. Please be specific with the description, Lot Number, PO etc. and specify the test desired. Please indicate the Test Code Number on the form also. This will greatly reduce turnaround time necessary to generate an accurate, final report.
Final Reports
Upon completion of test, a final report will be issued and all records and raw data will be held for five years.
Highlights For You
How To Calculate Allowable Limits For Ethylene Oxide Sterilization
Learn what ethylene oxide residuals are and how to calculate allowable limits for EtO-sterilization of medical devices and products.
Tolerable Exposure Limits For Ethylene Oxide Sterilized Medical Devices
Learn about ethylene oxide residuals and how to calculate tolerable exposure limits for EtO-sterilized medical devices and products.
Key Differences Between USP 1115, USP 1116 and USP 1211
Learn about USP regulations regarding non-sterile and aseptic processes, and sterility assurance and how these relate to regulatory testing requirements.
