Testing Procedure

The procedure for sterility testing involves subjecting samples of the pharmaceutical product to conditions conducive to microbial growth. The samples are then observed over a specified period, typically ranging from 7 to 14 days, to monitor for any signs of microbial proliferation.

Sterility

Our Facility

At Tentamus Pharma UK, we have a dedicated cleanroom equipped with three Grade A Integrated VHP Isolators, giving us the largest capacity for Sterility Testing in the UK. Inside our cleanroom, strict aseptic techniques are employed throughout the testing process to minimize the risk of introducing contaminants. This includes working within a controlled environment, using sterile equipment and materials, and adhering to established protocols for sample handling and manipulation.

Testing Specifications

1.     Membrane Filtration

2.     Direct Inoculation

Regulatory Compliance

Sterility testing in the UK is governed by regulatory requirements set forth by the European Pharmacopoeia (Ph. Eur.). These regulations dictate the specific methods, acceptance criteria, and validation protocols that must be followed to ensure the reliability and accuracy of the testing process for pharmaceuticals.

Sterilitypage

Importance of Sterility Testing

The results of sterility testing play a crucial role in determining the release or rejection of pharmaceutical products or medical devices for distribution and use. A product that fails to meet the established sterility criteria may pose a significant risk to patient safety and must be appropriately addressed by the manufacturer.

Benefits of Sterility Testing

  • Patient Safety: Ensures products are free from harmful microorganisms.
  • Quality Control: Maintains the integrity and effectiveness of medicinal products.
  • Regulatory Compliance: Meets the stringent requirements set by regulatory bodies.
  • Product Reliability: Ensures that products meet the highest standards of quality and safety.

Sterility testing is a fundamental quality control measure in the pharmaceutical industry. It serves to safeguard the integrity and effectiveness of medicinal products, as well as medical devices and instruments, upholding the highest standards of patient care and safety.

We Value Your Privacy
We use cookies on our website. Some of them are essential, while others help us to analyze how this website is being used and to allow you to contact us through our website, i.e. use the chat widget. You can change your decision at any time.
We Value Your Privacy
Statistics
We use these technologies to analyze how this website is being used.
Name Google Analytics, Google Tag Manager
Provider Google Ireland Limited, Gordon House, Barrow Street, Dublin 4, Ireland
Purpose Cookie by Google used for website analytics. Generates statistical data on how the visitor uses the website.
Privacy Policy https://policies.google.com/privacy
Cookie Name _ga, _gat, _gid
Cookie Expiry 2 years
Customer Interaction
These technologies will allow you to contact us through our website, i.e. use the chat widget.
Name LiveChat
Provider LiveChat Software S.A., ul. Zwycięska 47, 53-033 Wroclaw, Poland
Purpose Communication with clients via online chat using the API of the chat service LiveChat.
Privacy Policy https://www.livechat.com/legal/privacy-policy/
Cookie Name __lc_cid, __lc_cst
Cookie Expiry 2 years
Essential
Technologies required to enable the core functionality of this website.
Name Cookie Consent
Provider Owner of this website, Imprint
Purpose Saves the visitors preferences selected in the cookie banner.
Cookie Name ws_cookie_consent
Cookie Expiry 1 year