Sterility
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
M100
Biological Indicator (BI) Sterility
M105
BI Enumeration
M110
USP Sterility – Immersion
M120
USP Sterility – Membrane Filtration
M150
ISO/AAMI Product Sterility (100 Product Dose Verification)
M153
ISO/AAMI Product Sterility (10 Product VDmax Sterility)
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.
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