Avoid a media related 'positive' media fill test -use Merck's irradiated TSB for media fill applications.

Aseptic manufacturing is one of the most demanding operations conducted in the pharmaceutical industry and is a systemized process involving several individual contamination control elements. Sterile filtration is the key element for removal of viable contaminants in the process.

The FDA guidelines prescribe a media fill test for testing the overall sterility of an aseptic production line and this test is one critical requirement for sterility assurance.

Process sterility must be simulated by performing a production run using a microbiological growth medium in place of actual product (media fill).

The medium is subjected to exactly the same conditions as the product, including filling and closing, to ensure that there is no microbial contamination occurring during the process. The sterility of production lines has to be checked at regular intervals depending on batch sizes and changes in the process.

Merck's gamma-irradiated TSB and non-animal derived TSB are particularly suitable for the sterility testing and validation of aseptic filling procedures and will ensure the integrity of the aseptic process simulation. The irradiation processes ensures against a media-related 'positive' media fill test because bacteria, yeasts, moulds, spores and mycoplasmas are killed. Mycoplasmas in particular are troublesome contaminants because they can pass through any existing 0.2 µm pore-size filter. The only way of assuring a sterile medium is therefore to use our gamma irradiated TSBs. Each lot is mycoplasma-tested by quantitative PCR which demonstrates the absence of mycoplasmas.

The required amount of gamma-irradiated TSB depends on the size of the units used, ranging from 150 to 10,000 litres of liquid TSB.

Benefits of Merck Irradiated TSB

• Triple wrapped, ready for clean room use.
  
• Validated irradiation process using 48-68 KGy gamma, protects against media related 'positive' media fill tests, because bacteria, yeasts, moulds, spores and mycoplasmas are killed.
  
• Each lot of irradiated TSB is mycoplasma-tested, and absence of this difficult contaminant is confirmed through quantitative PCR.
  
• Specially selected raw materials ensure maximum recovery and growth.
  
• Sterility tested at 20-25°C and 30-35°C
  
• Certificates of origin and suitability.
  
• Complete traceability documentation to ensure compliance with BSE/TSE requirements.
  
• Only Merck produces media in granular form, which results in less dust during preparation and safeguards the health and well-being of production and laboratory personnel.