The DSM production site of Delvotest® products, located in the Netherlands, is operating under strict quality management procedures and is certified according to ISO 9001:2015. The Delvotest® Microbial inhibition tests such as ampoules and plates are produced in a cleanroom environment. Environmental monitoring of the cleanrooms and other production rooms is used to control the risk of (microbiological) contamination of the products.
Quality Control
All batches of Delvotest® ampoules and plates undergo specific quality testing before being approved for release to the customer.
The quality tests are performed at different stages of the production process and are not limited to the ones described in this document.
Incoming goods
All raw materials, consumables, packaging materials and service items are checked for compliance with the set specifications by the quality department.
Intermediate testing
Quality procedures are in place for intermediate and final product lines.
Sensitivity testing
The performance of the batch is verified for the detection of antibiotics using positive and negative milk samples.
Infection control testing
Delvotest® product samples, as well as environmental infection controls, are collected during production according to strict protocols and tested for microbial contamination which may have negative effect on the test performance.
Sealing integrity test
Sealed samples from each produced batch are collected and the seal integrity is tested with the use of a vacuum pump at several stages to guarantee full sealing of the products.
Packaging inspection
During the packaging process all products are visually inspected before being placed in the final packaging.
When compliant to all internal specifications and tests, the product is positively released, and a certificate of conformity is issued for the specific batch.
Please do not hesitate to contact us should you have any questions concerning this matter.
Refer following link as well:
Understanding ISO 9001: Ensuring Quality and Trust - Delvotest - Help Center (trengohelp.com)