All Microbiologics enumerated microorganism preparations and KWIK-STIK™ Plus products come with a Certificate of Assay. This certificate is included on the product's label. The "peel-off" feature of the certificate facilitates a permanent record and provides documentation regarding the products quality assurance; which may include the mean assay value and the number of passages the microorganism preparation is removed from reference culture status.

The Certificate of Quality is included with each shipment from Microbiologics and can be found on the back of the packing slip. This certificate serves as a permanent record and provides documentation regarding the product's quality assurance.

A statistical sampling plan and validated assay method are performed on pellets from each final product. All test results must fall within stated control limits as described in the Instructions for Use. The test results are used to calculate the mean (average) assay value (CFU per pellet, or CFU per 0.1 ml) for each lot of enumerated microorganism preparation. The mean assay value is recorded on each Certificate of Assay.

Microbiologics provides assurance that the critical growth requirements such as, biochemical activity, selective and differential properties, serology characteristics, antimicrobial susceptibility, and key substrate reactivity, which are manifested in the reference culture, are manifested and unaltered in the final fabricated product. A specified set of tests are conducted upon receipt of the reference culture to create a phenotypic profile for each microorganism product. These testes are repeated at key steps during processing, and again with the final fabricated product. The phenotypic profile documents the authenticity of the reference stock culture as a derivative of a reference culture. The test results are documented on the Certificate of Analysis, available at www.microbiologics.com, for each microorganism lot.

For microorganism cultures, preservation is a process employed to keep the culture alive, intact, and in an unaltered condition. Microbiologics employs the method of lyophilization, freeze-drying or sublimation (solid phase of ice directly to the gas phase of vapor without passing through the liquid phase of water) to prepare preserved microorganism preparations.

Process controls are either qualitative (presence/absence) or quantitative (enumeration). These enumerated microorganism preparations are used on a regular basis (e.g., daily) to support and document that a test method is "in control".

This quality assurance function is offered by an independent third party and laboratories participate in a PT Program on a subscription basis. All the participating laboratories receive, process, and test a challenge material for the presence or absence of a target microorganism(s) or enumerate a target microorganism(s). All the test results are analyzed and a value is established based on the consensus of the participating laboratories. The consensus is commonly established without regard for the specific test method(s) employed.

This quality assurance function is most commonly a self-imposed function. A corporate laboratory will select a challenge material and request that other laboratories in the corporate net process and test the challenge material for the presence or absence of a target microorganism(s) or enumerate a target microorganism(s). All the test results are analyzed and a value is established based on the consensus of the participating laboratories. The consensus is commonly established without regard for the specific test methods.

Purity testing is done on each lot of final product, to provide assurance that products are free from extraneous contaminating microorganisms.

The microorganism is manufactured to deliver a pre-determined concentration of colony forming units (CFU) when processed as directed.

The recovery of colony forming units (CFU) for pellet preparations of a retail reference stock culture must exceed 1,000 CFU per pellet for bacteria and yeast, or 100 CFU per pellet for fungi. An enumeration of colonies is performed on pellets from each lot of final product. The minimum recovery is stated on the Certificate of Analysis, available at www.microbiologics.com, for each microorganism lot. This minimum recovery is guaranteed to be valid until the stated expiration date.

A reference culture is a microorganism preparation that is acquired from a culture type collection.

A reference stock culture is a microorganism preparation that is derived from a reference culture. Guidelines and standards outline how reference stock cultures must be processed and stored. In-house laboratory preparations and commercial preparations can meet reference stock culture criteria.

In the laboratory, records may be required to provide documentation or evidence that a working stock culture can be traced back to a reference stock culture and ultimately traced back to a reference culture. Microbiologics microorganism preparations are traceable to a reference culture. Documentation records a chain-of-evidence to ensure that each final fabricated product can be traced to a reference culture.

Validation is a process by which established scientific measurements, testing methods, sampling, and analysis are employed to document the anticipated, consistent, and reproducible performance of a device or product.

Verification is a process by which selected inspection, measurement, and testing is performed to determine that the objectives of the validation process have been met.

This is a guarantee from the manufacturer that a product will produce stated product specifications and performance when it is stored, processed, and used as directed before the expiration date.

A working QC stock culture is a microorganism preparation that is derived from a reference stock culture and in many microbiology disciplines is used as quality control challenge material on a regular, day-to-day basis. Guidelines and standards outline how working stock cultures must be processed and how often they can be sub cultured.