Manufacture of pre-prepared media is carried out using only raw materials sourced from approved suppliers and manufacturers, in a state of the art ISO-validated facility
Biotrace International's range of pre-prepared media (Biotrace PPM) has been specifically designed to meet the needs of the pharmaceutical industry.
Complying with GMP regulations and customer audit requirements, the range is supported by a high level of customer service.
Quality systems and procedures play a critical role throughout the production and distribution process. Manufacture is carried out using only raw materials sourced from approved suppliers and manufacturers, in a state of the art facility that includes a 100m2 cleanroom validated to ISO 14644-1.
All Biotrace PPM products are routinely tested for sterility, performance, pack integrity and accuracy of documentation.
Performed by trained in-house microbiologists, QC testing includes sterility, physical and growth promotion tests, with all specifications and processes conforming to USP, BP and EP guidelines.
The manufacturing site of the culture media is, says Biotrace, the first and only in Europe to achieve the latest GMP accreditation from the pharmaceutical quality group, PS9100. Providing flexibility of supply, a large buffer stock capacity ensures faultless routine delivery and quick response times for any emergency requirements.
A range of plated and liquid culture media is available.
This includes triple-wrapped and irradiated plated media for environmental monitoring comprising of settle plates, contact plates and 140mm air sampler plates for use with Air Trace air samplers for environmental and compressed gas monitoring.
Also available are isolation, identification and enumeration media.
A selection of liquid sterility testing media and rinse solutions in bottles and bags complement the media portfolio.
Biotrace PPM is part of Biotrace International's growing product offering to the pharmaceutical industry, which also includes Biotrace ATP-based rapid hygiene monitoring systems, an extensive range of dipslides, and the recently launched Biotrace Air Trace air samplers for environmental monitoring and compressed gas.
