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PREPARED MEDIA IS USED IN ENVIRONMENTAL MONITORING AND TESTING APPLICATIONS

Healthcare, pharmaceutical and industrial organisations rely on quality-assured prepared media every day

Maintaining cleanrooms and other aseptic areas to the most stringent regulations, plus validating sterility testing processes, requires quality assured prepared culture media.

The EU GMP Annex 1 highlights an increasing need for organisations operating in pharmaceutical and medical device manufacture, and other industrial sectors, to reduce the risk of contamination wherever possible.

Businesses that rely on clean room areas for their manufacturing will need to use prepared cultured media including poured media plates, bottled media, broth bags, ampoules - and perhaps even some bespoke media and accessories - to match the specific requirements of both organisation and facility.

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The Pharmaceutical and Cleanroom Industry's Pocket Guide to Prepared Media

Got questions about selecting the best media for your business, storage best practice or generating a bespoke formulation?

Our guide will help.

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Prepared Media Types

Agar Plates

Used in clean rooms, isolators, operating theatres, offices, factories and waste processing sites.

Active and passive air sampling use settle plates, while surface testing uses contact plates.

Bottled Culture Media

There are many different kinds of bottled media. They are used in pharmaceutical, food and sterility testing processes.

Typically used to test for, cultivate and isolate various microbes across healthcare products, food, water treatment samples, environmental samples and more.

Tryptic Soy Broth & FTM

Used to detect the presence of bacteria and fungi in the pharmacopoeia sterility test.

TSB is used to detect aerobic bacteria and fungi; FTM to detect anaerobic bacteria. TSB is also used in universal operator transfer validation.

Clean Room Monitoring

Prepared media plays a vital role in all aspects of environmental monitoring in the clean room. Most businesses operating within pharmaceutical manufacturing and related industries will use a combination of active and passive air samples. Both types of equipment rely on prepared media on which to collect and recover colony forming units in the air.

Clean room personnel are also monitored using various forms of prepared media, whether their gowns are tested directly with contact plates or swabbed for microbial contamination.

The EU GMP Annex 1 guidelines act as the industry standard to which all businesses operating in this sector must comply. As we work towards global standards, this legislation will become increasingly important.

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The Environmental Monitoring Process and Validation Guide

Confused about creating an EM program that fits your business and budget and complies with the latest EU GMP Annex 1 revision?

Our guide will help.

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Process and Operator Validation

Process and operator validation are critical to the quality assurance of the finished product. Process validation establishes, by objective evidence, that a process produces consistent results to meet predetermined specifications.

Validation must be planned and documented, with results recorded in accordance with a program. Using the correct prepared media for each validation is critical, with bespoke formulations necessary on occasion.

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Failure is Not an Option: Why Sterility Testing is so Important

Want to know how to avoid a sterility test failure and how  your EM program can help? Then this guide is for you.

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Manufacturing, Packaging and Storing Culture Media

Manufacturing processes, packaging and storage are essential to the quality of prepared media. Aseptic process testing and validation relies on the integrity of the media used. Strict production conditions are a given, as are post production testing methods.

The importance of secure packaging can't be overlooked; any contamination in transit will render the media useless. The final critical consideration is storage, to maintain the viability of the media prior to use.

See how gamma-irradiated packaging protects prepared media in this short video.

Guaranteeing consistent, reliable prepared media requires quality-assured manufacture processes, packaging and storage.

Gamma-irradiated media is rigorously quality checked and triple wrapped before being passed through an additional sterilisation process. Post irradiation testing confirms growth properties and pH.

Specific Culture Media Formulations

As new medications are developed and microbial threats evolve, the demand for bespoke formulations is increasing. Complex products may be unsuitable for standard membrane filtration sterility testing, for example. This will require a specific broth formula for direct inoculation.

The need for small batches of formula is increasing in tandem, allowing manufacturers to create very specific testing processes where necessary. Other bespoke needs can also include unique packaging design or environmental monitoring accessories.

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Redipor Culture Media Price List

Take a look at the latest Redipor price list for ready-to-use culture media in plates, bottles, bags and ampoules, from our extensive range.

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Asked Questions

Our environmental monitoring requirements have changed. Can you help us create new processes?

Yes. We have almost thirty years' experience with helping pharmaceutical and associated industries deliver environmental monitoring processes critical to the manufacture of heavily regulated products.

We supply every component you need to create environmental monitoring processes. We also offer bespoke formulations, accessories and even packaging solutions for organisations with very particular needs.

Get in touch today. Let's discuss your requirements.

Do I need to store my prepared media in the fridge?

The majority of our prepared media can be stored in ambient conditions, not exceeding 25ºC. There are only a small number of very specialist products that require different storage conditions.

We have never specified refrigeration as a storage condition for our general media as this causes excess condensation and can result in very wet agar, rendering it impossible to use.

What is the maximum exposure time for settle plates?

Settle plates are used to monitor the level of viable particles in the environment through a process of passive air sampling. A viable particle settles on agar plates at a rate dependent on its characteristics and the airflow in the environment.

EU GMP Guide Annex 1 has recommended that 90mm settle plates can be exposed in cleanroom environments for up to 4 hours. However, agar plates may dry out during long exposures where the rate of air exchange is high. So, it might be necessary to use deep filled settle plates, or replace the settle plate after a shorter time to ensure satisfactory growth promotion after exposure.

What is the difference between general purpose and selective growth media?

General purpose media have nutrients that support the growth of most non fastidious culturable microorganisms.

Selective growth media contain components that will inhibit the growth of some types of microorganisms, while supporting the growth of others.

General purpose media, such as Tryptone Soya Agar, are used to produce total counts. While selective media, such as XLD for Salmonella species, are used to test presence/absence of specific types of microorganism.

How much air should we sample?

Typical requirements suggest 1,000 litres per air sample in high risk areas, such as: grade A filling lines, grade B clean rooms, operating theatres etc. As the criticality of the area reduces, the sample size can be reduced. The aim is to achieve a representative sample; so where higher counts would be expected, a smaller sample produces a more realistic number of cfu to count.

Should I use contact plates or Petri dishes in my air sampler?

SAS samplers were originally designed for Contact plates, however, a Petri dish option has been available for a number of years. It is really a personal choice, although this should be decided at time of purchase, as the sampler will be specifically configured for the plate type chosen. There are advantages for each version and we would be happy to discuss your specific needs.