Redipor New Products - From Enquiry to Production

By Andrew Ramage

The responsibilities and procedures for new Redipor products

As I settle into my new role here at Cherwell Laboratories one of my main tasks is to manage the process of getting Redipor® new product requests from the sales office down to QA and Production and ultimately to the customer.  As a smaller manufacturer of prepared media we are able to produce small batches of bespoke media or buffers to the customer’s specification.  This month’s blog will hopefully give you an appreciation of what...

Read More

Pharmig Conference - March 2016

By Gill Power

Keeping up to date with topical information and views on microbiologically related topics

The Oxfordshire Golf Club, Hotel and Spa was the venue for two Pharmig conferences on the 2nd and 3rd of March.  The 2nd March conference was the Best Practices in Environmental Monitoring: Covering Steriles and Non-Steriles.  The 3rd March conference was the Latest Updates on Sporicides - As Part of Your Transfer Process aimed mainly at NHS staff.  Cherwell Laboratories was represented on both days by...

Read More

Pitfalls to Avoid in Growth Potential (GPT) Testing

By Gill Power

Best Practice for Growth Potential Testing

It seems that there is a struggle to perform GPT in a co-ordinated and well documented approach. GPT testing is a regulatory expectation from a cGMP microbiology laboratory and there have been some issues with trepidations and data integrity observations in the microbiology labs around the subject of GPT testing. I have written what I believe is the best practice for GPT which you can find linked as a separate document. For advice on what pitfalls...

Read More

Why Use Neutralisers in your Environmental Monitoring Plates?

By Gill Power

For those of you working to the orange guide and/or the guidance in the European Pharmacopoeia you will notice the absence of specific guidance on how to monitor your cleanrooms. The USP <797> however does give specific advice on what media to use and specifies that surface sampling must be supplemented with additives to neutralise the effects of disinfectants.

Read More

Pharmig 2015 Annual Conference

By Gill Power

Keeping up to date with current topics and developments in microbiology

The annual Pharmig conference took place at the Nottingham on the 25th and 26th November 2016. For those who haven’t been to this event it is a mix of presentations by leading industry figures and open discussion sessions covering the latest “hot topics” where delegates can share experiences and discuss the latest regulatory information. There were also a large number of trade stands selling everything the...

Read More

Considerations for Environmental Monitoring Plates

By Gill Power
In many industries there is a need to monitor for both viable and non-viable particles within controlled spaces. The methods for the viable environmental monitoring of controlled spaces, such as within pharmaceutical clean rooms can be split into passive or active methods.
Read More

Finding Good Industry Information

By Gill Power

Useful links

How to find the best industry information and guidance?

With the explosion in the sheer volume of information now available on the internet it can be difficult to know where to find reliable answers to questions. Within the pharmaceutical and associated industries regulatory documents, such as EU GMP, provide the framework within which compliance must be sought. Interpretation and implementation of these regulations can be challenging.

Read More

Where Next For 14698?

By Gill Power

Revision to ISO bio-contamination cleanroom standard stopped or just delayed?

International Standards Organisation (ISO) has two series of clean room standards, ISO14644 and ISO14698. Both standards have been under review for many years and whilst sections 1 and 2 of ISO14644 have been issued as draft international standards (DIS), further work on ISO14698 for bio-contamination has stopped.

Read More

Keep It Clean

By Gill Power

Our Sales Manager, Andrew Barrow, offers an insight into monitoring cleanrooms and reducing contamination risk.

Pharmaceutical cleanrooms are classified as class 5 to class 8 according to ISO standard 14644-1 based on number of particles of specified size per m3 air. They are graded A – D by the MHRA Orange Guide (EU Guidance on GMP) based on similar particle ranges at rest and in use, with additional limits for microbial contamination in operation. The Orange Guide demands microbiological...

Read More

Old Fashioned Customer Service

By Gill Power

 Is it being overtaken by modern day technology?

As a family business of over 40 years standing, Cherwell Laboratories has developed a reputation in the market based on its products and values. We hope we offer a range of high quality irradiated media products and solutions to our customers, but just as important, we strive to offer great customer service.

In today’s technology driven world it is all too easy to succumb to clever, cloud based IT solutions or converged communications and all...

Read More

Subscribe to Email Updates

New Call-to-action
New Call-to-action
New Call-to-action