Highest degree of product Quality
It is the policy of bioTRADING to achieve the highest degree of product quality, ensuring that processes and services are continuously improved and in line with international standards and customer requirements.
ISO 9001:2008
The company's total commitment to quality and performance was reflected in 1994, when bioTRADING successfully achieved ISO 9001 accreditation. Furthermore, partly due to many external audits being regularly undertaken at our facility, our quality management systems is adapted to GMP. Click here for the ISO 9001:2008 certificate.
ISO 11133 & Harmonized USP/EP/JP
Our Ready Prepared Culture Media meet the ISO 11133 and harmonized USP/EP/JP formulations and performance criteria*.
Quality Control
Extensive quality control for sterility and bacterial growth parameters among others are carried out by our laboratory. Every batch of media is tested to international standards or to customer specifications. Organism challenges and sterility testing can be tailored to duplicate your present in-house methods, saving the customer a lot of time; less quality control to be performed by the customer.
Quality Control Certificates can be downloaded using a login password.
FDA 21 CFR part 11 compliant
Our facility- and environmental-monitoring systems are ‘FDA 21 CFR part 11 compliant’.
State-of-the-art production facility
The new ultramodern production facility in Mijdrecht, opened in 2009, is designed and equipped to meet pharmaceutical regulations, for Ready Prepared Culture Media. For the production of Ready Prepared Culture Media we use some of the most advanced equipment available, including: magnetic stirred media preparation vessels, water cascade autoclaves, multi-lane pneumatic petri dish filling machines, 2-D-datamatrix barcodes and more.
Audit report quotes
- 'The quality documentation system of bioTRADING is meeting the current ISO and GMP standards'.
- 'A strongly developed computerized system controls orders, the process, delivery to customers as well as quality and traceability of microbiological media'.
- 'Hygiene, housekeeping, storage space and routing were seen as very impressive e.g. bioTRADING clearly demonstrated to have quality high in their standard'.
- 'The routing of raw materials to end products is very well organized'.
- 'All critical process steps are automatically monitored and controlled'.
- 'Equipment is validated and maintained on a regular basis and records are kept'.
- 'Traceability is assured. Traceability is possible up-stream as well as down-stream'.
- 'Every raw material and end products including process runs can be traced to the customer'.
- 'The appropriate quality, scientific and technical knowledge of the participants was experienced during the audit'.
- 'The plant was found to be well designed for its purpose.
- 'The impression of the employees was motivated and alert personnel who were very well trained for their jobs'.
- 'The auditors concluded that the quality of the products manufactured by bioTRADING is assured by the procedures and the quality system in place'.
- 'The audit team can confirm that bioTRADING complies with our standards for GMP suppliers'.
(*where applicable)
