News

DOES YOUR CLEANROOM MEET THE NEW STANDARD?

February 2021 is the date by when the 34 CEN nations (primarily Europe and Turkey) have to implement EN 17141:2020 as a national standard. This new Cleanroom standard and associated controlled environments – Biocontamination control standard, sets expectations for risk assessment, viable contamination control, viable monitoring methodology and monitoring frequency.

The new cleanroom standard applies to pharmaceutical, medical device, hospital/healthcare and food cleanrooms. EN 17141:2020 covering microbiological contamination sits nicely alongside the ISO 14644 series that relates to cleanroom non-viable contamination monitoring and classification.

What is a cleanroom?

A cleanroom is a controlled environment where pollutants like dust, airborne microbes, aerosol particles and chemical vapours are kept at specific levels to minimize contamination. These environments are used in industries such as pharmaceuticals, biotech, medical device and life sciences where small particles can adversely affect manufacturing processes.

In a cleanroom, the concentration of airborne particles is controlled to specified limits. To achieve this, the air in a cleanroom is repeatedly filtered through High Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) filters to remove internally generated contaminants.

Cleanrooms are classified based on the cleanliness level of the air inside them. This classification is determined by the number and size of particles permitted per volume of air. For example, no more than 100 particles (0.5 microns or larger) per cubic foot of air.

Associated controlled environments are areas adjacent to or within the cleanroom that also have controlled levels of contamination. These areas may include gowning rooms, pass-throughs, and material airlocks. They play a crucial role in preventing the ingress of contamination into the cleanroom.

The new Biocontamination control standard sets expectations for risk assessment, viable contamination control, viable monitoring methodology and monitoring frequency in these controlled environments. It aims to ensure that cleanrooms and their associated controlled environments maintain the necessary cleanliness levels to prevent product contamination, thereby ensuring quality and safety.

cleanroom

NEW EX MHRA INSPECTORS JOIN THE EPIC TEAM

Team

We are very pleased to announce that Peter Coombs and Claire Glenister have recently joined the EPIC Auditors team. This will bring the number of Ex MHRA Inspectors working with EPIC Auditors to fourteen.

With access to such a wide range of knowledge and experience, we are confident that we can provide GXP support throughout the medicinal product lifecycle and help all our clients to improve their GXP quality systems and regulatory compliance.

If you need our help and support then please don’t hesitate to contact us.

Telephone Number: +44 (0)1244 980544

Peter Coombs
Peter Coombs
Claire Glenister
Claire Glenister

REMOTE PHARMACEUTICAL AUDITS AND SUPPORT

During the Covid 19 pandemic, like the MHRA, and like many other businesses, EPIC Auditors has been providing remote pharmaceutical audits and support.  Helping companies to meet the regulatory requirements and to develop the quality systems essential to support much needed clinical trials for various Covid 19 treatments.  

As part of this facilitation work, EPIC have developed a set of generic SOPs for key elements of the quality system that companies can then adapt to their own business framework and style. We now have a set of 10 SOPs covering:-

  • Quality Management Reviews
  • Deviations
  • CAPA
  • Complaints
  • Recall
  • Change Control
  • Quality Risk Management
  • Documentation
  • Self – Inspection
  • Supplier Evaluation

You can purchase this set of SOPs for £2700 by contacting:   enquiries@epic-auditors.com

We also have a  set of SOPs specifically for manufacturers of IMPs covering:

  • Importation of IMPs
  • Batch Certification
  • Reference & Retained samples for IMPs
  • Complaints
  • Recall

Please let us know if you are interested in remote audits and support, using the same e mail address.

In addition to providing support for Covid trials, we have also adapted to providing routine remote pharmaceutical audits of all kinds including internal audits and supplier audits as well as mock MHRA inspections. Advances in technology are helping us to overcome the challenges of remote auditing but it is likely that the efforts will not be wasted, as remote auditing is probably going to be with us for some years to come.

If you need our help and support then please contact us on  +44 (0)1244  980544

or email us at:  enquiries@epic-auditors.com