Thermo Scientific and Remel Culture Media Range Complying with MLT from Ph. Eur. USP and JP

Thermo Scientific and Remel have introduced a complete portfolio of culture media for the microbiological examination of non-sterile pharmaceutical products, as recommended in the Harmonised Microbial Limit Tests chapters in the Ph. Eur, USP and JP^1,2,3.

The fully validated portfolio (validation documents available on request) includes dehydrated culture media and prepared media for both microbial enumeration tests and specific micro-organism testing.

' Rigorous quality assurance and quality control systems ensure that our media meet the technical specifications and regulatory standards that pharmaceutical microbiologists require,' commented Maria Higgins, pharmaceutical applications manager, Thermo Scientific. ' Our carefully sourced raw materials are fully traceable. Quality control is performed quantitatively and qualitatively, using the recommended strains and incubation/temperature parameters outlined in the harmonised MLT chapters of the Ph. Eur, USP and JP. Pharmaceutical companies can therefore have complete confidence in our portfolio.'

Thermo Scientific and Remel media are produced in specialised production facilities in the UK, Germany, USA, Canada and Australia. These units utilise state-of-the-art equipment and carefully controlled environments to ensure consistent, high-quality products made to the latest international standards. On-site inspections and audits are welcome and can be arranged through Thermo Scientific and Remel representatives.

The complete range of the specified ATCC® microbial strains recommended by the harmonised MLT chapters of the Ph. Eur, USP and JP are also available as Thermo Scientific Quanti-CultPLUS™ (vials that consistently deliver a specific range of colony forming units) and Thermo Scientific Culti-Loops™ (stabilised micro-organisms, safely and conveniently presented in disposable bacteriological loops).

Quanti-CultPLUS and Culti-Loops are ideal for use in a number of quality control procedures including: performance testing and method validation; microbial limit tests; bioburden testing; bacteriostasis and fungistasis testing; and growth promotion testing. They can also be used in the maintenance of stock cultures. Quanti-Cult PLUS and Culti-Loops have been added to the ATCC® (American Type Culture Collection) Licensed Derivative® Program. Look for the ATCC Licensed Derivative Emblem TM for products derived from ATCC® cultures.

The Thermo Scientific world class dehydrated culture media manufacturing facilities in Basingstoke, UK are FDA- audited and have been registered to ISO 9000 since 1990, with additional registration to ISO 13485 for medical devices since 2004.

Remel is regulated by the FDA under the Code of Federal Regulations (CFR) Title 21: Food and Drugs. Compliance includes adherence to the current Quality System Regulations (QSR), formerly the Good Manufacturing Practices (GMP), of CFR 21. Remel also holds an ISO Certificate of Registration for a Quality Management System compliant with the requirements of ISO 9001:2000 Quality Management System Requirements and ISO 13485:2003 Quality Systems - Medical Devices - Particular Requirements for the application of ISO 9001, and CMD/CAS Medical Device Regulation.

For further details, contact your Thermo Scientific (contact details are at the top of this page) or Remel representative.

References
1. European Pharmacopoeia 6.1. 2.6.12 Microbiological Examination of Non-Sterile Products: Harmonised Method: Microbial Enumeration tests 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Micro-organisms. B. Harmonised Method. (2008).

2. US Pharmacopoeia 30. <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. <62> Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms. (2008).

3. Japanese Pharmacopoeia. 15th Edition. (2006).