Tepnel offers single harmonised non-sterile microbiology methods

Published: 15-Jul-2009

Tepnel Pharmaceutical Services is now able to offer the harmonised methods for non-sterile microbiological testing, making it quicker, more cost effective and easier for manufacturers to comply with the new regulations for European, US and Japanese Pharmacopoeias.


Tepnel Pharmaceutical Services is now able to offer the harmonised methods for non-sterile microbiological testing, making it quicker, more cost effective and easier for manufacturers to comply with the new regulations for European, US and Japanese Pharmacopoeias.

All substances with pharmacopoeial monographs are required to comply with USP/JP/Ph. Eur. with the new reference methods.

Non-monograph substances and monograph products to USP/JP also need to be compliant.

Non-monograph substances and monograph products to Ph. Eur. must be compliant by January 2010.

The harmonised method for specified micro-organisms also includes a new specific test organism (Candida albicans) and allows for variable sample quantity and changed limits depending on factors such as batch size and intended use.

Tepnel says the harmonised approach improves microbiological testing by changing to more modern media formulations. These improvements help drive efficiency by reducing the need for duplicate testing, which can streamline raw material, active ingredient or finished product release.

Tepnel has completed the method establishment for both parts of the Microbiological Examination of Non-Sterile Products tests, namely the Microbial Enumeration Tests and the Test for Specified Micro-Organisms. This methodology has been developed in line with the guidance from the commissioners of the British, European, US and Japanese Pharmacopoeias, which provide a single harmonised testing method.

  • Companies:
  • Gen-Probe Tepnel
See more

You may also like

Research & Development

Gen-Probe’s analytical service laboratories pass FDA inspection

Read more
Site already certified by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for GMP, GLP and GCP compliance

Trending Articles

  1. Lonza Capsules & Health Ingredients expands capsule manufacturing capacity in India and China New capsule manufacturing lines added at Lonza Capsules & Health Ingredients (CHI) facilities in Rewari (IN) and Suzhou (CN), highlighting the long-term strategic commitment to the business and the APAC region
  2. You need to be a subscriber to read this article.
    Click here to find out more.
    How CDMOs can set a new gold standard when it comes to going green Sustainability is more than a feel-good initiative or a choice; it’s a strategic imperative. Not missing a beat, pharma companies have been making a concerted effort towards positive change, reports Tim Lowery, President of JSR Life Sciences and CEO, KBI Biopharma
  3. Novo Holdings completes acquisition of Catalent Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark
  4. Resolving capping issues in tablet manufacturing Natoli explores the various causes of capping and the methods to prevent it
  5. You need to be a subscriber to read this article.
    Click here to find out more.
    Industrial data mastery: navigating the 2025 landscape As industrial manufacturers contend with the ever-increasing volume and variety of operational data, the year ahead promises both complexity and opportunity

Upcoming event

EMPQ Essentials and Real-World Strategies for Successful Cleanroom Qualifications

16 January 2025 | Virtual See all

You may also like

Research & Development

Gen-Probe’s analytical service laboratories pass FDA inspection

Site already certified by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for GMP, GLP and GCP compliance
Research & Development

Gen-Probe expands service offering in Manchester, UK

Increases footprint and hires two managers
Analysis

FDA clears first nucleic acid amplification test to detect Trichomonas Vaginalis

APTIMA assay will improve detection of a potentially serious sexually transmitted infection that is common in women of all ages
Media

Gen-Probe completes acquisition of Tepnel Life Sciences

Gen-Probe has finalised its £92.8m (Euro 103m) purchase of UK-based Tepnel Life Sciences
Media

Gen-Probe makes recommended cash offer for Tepnel Life Sciences

<p>The directors of Gen-Probe and UK-based Tepnel Life Sciences have reached agreement on the terms of a recommended cash offer to be made by Gen-Probe for Tepnel. The offer values Tepnel at approximately

Tepnel awarded BBSRC grant in molecular diagnostics development

Technology that promotes the rapid detection and identification of pathogenic micro-organisms known to cause fatal infections in humans is to benefit from funding from the Biotechnology and Biological Sciences Research Council (BBSRC).

Abcam to distribute Tepnel's diagnostic and research products

<p>UK-based international molecular diagnostics and research services company Tepnel has signed a two-year global distribution agreement with one of the world's largest online supplier of antibodies.</p>
Subscribe now