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.
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.
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.
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.
The European Pharmacopoeia (Ph. Eur.) is a reference work for the quality control of medicines. The official standards within it provide a scientific basis for quality control during the entire life cycle of a product. The general microbiology text in the Ph. Eur. is harmonised with the corresponding chapters of the United States and Japanese Pharmacopoeias, to enable the free movement and trade of medicines within Europe and other countries.
We have created a table to show the Redipor range of prepared media from Cherwell that is formulated and performance tested in accordance with the requirements stipulated within the European Pharmacopoeia. For example R2A agar for the microbiological monitoring of water; Soya-bean Casein Digest Medium (Tryptic Soy Broth) used in sterility testing; Sabouraud Dextrose Agar (SDA) and Casein Soya Bean Digest Agar (TSA) for microbial enumeration tests and culture media to test for specified micro-organisms, such as MacConkey agar and broth used for E. coli.
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.
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.
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.
This diagram shows our Redipor® Triple-wrapped irradiated plates packaging. It comprises of three layers, with two layers of flow wrap and a large sealed polybag.
The illustration demonstrates the sterility assurance with each layer, following exposure to gamma radiation.
It allows the plates to be easily handled without the risk of introducing contaminants, while transporting product through each stage of a facility. Maintaining conditions for the agar and providing consistent, reliable prepared media that delivers confidence in sampling.
This is a representation of our standard triple wrap that can be applied across our range of plated product. We do offer other presentations, please contact us for more information.
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.
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.
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.
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.
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.
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.
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.
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.