Oxoid And Remel Introduce Range Of Culture Media That Complies With The Microbial Limit Tests From Ph. Eur. USP And JP
Oxoid and Remel, world leading microbiology brands, have introduced a complete portfolio of culture media for the microbiological examination of non-sterile pharmaceutical products, as recommended in the Harmonized Microbial Limit Tests chapters in the Ph. Eur, USP and JP1,2,3.
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 MarĂa Higgins, pharmaceutical applications manager, Oxoid. "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 harmonized MLT chapters of the Ph. Eur, USP and JP. Pharmaceutical companies can therefore have complete confidence in our portfolio."
Oxoid 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 Oxoid and Remel representatives.
The complete range of the specified ATCC® microbial strains recommended by the harmonized MLT chapters of the Ph. Eur, USP and JP are also available as Oxoid Quanti-CultPLUS™ (vials that consistently deliver a specific range of colony forming units) and Oxoid 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.
For further details, contact your Oxoid or Remel representative, email val.kane@oxoid.com or visit www.oxoid.com or www.remel.com.Oxoid and Remel are part of Thermo Fisher Scientific Inc., the world leader in serving science.
About Thermo Fisher Scientific:
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With an annual revenue rate of more than $10 billion, we employ 30,000 people and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings. Serving customers through two premier brands, Thermo Scientific and Fisher Scientific, we help solve analytical challenges from routine testing to complex research and discovery. Thermo Scientific offers customers a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions. Fisher Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety and education. Together, we offer the most convenient purchasing options to customers and continuously advance our technologies to accelerate the pace of scientific discovery, enhance value for customers and fuel growth for shareholders and employees alike. Visit www.thermofisher.com.