Media fill-sterility test for pharmaceutical industries
Proveedor: Merck
Be assured that Merck offers the quality TSB that you are looking for in your aseptic process simulation.
- Triple bagged and ready for cleanroom use: Three layers of protection allow you to add directly to production vessels and delivery systems.
- Irradiation process using 48-68 kGy gamma: Robust validated process ensures that media related positives are eliminated from your aseptic process simulation. The irradiation process inactivates any viable bacteria, yeast, mold, spores and Mycoplasma.
- Every lot is Mycoplasma tested: Validated PCR technology QC testing process for Mycoplasma detection to ensure absence of this difficult contaminant.
- Growth promotion and sterility tested exceeding expectations of USP/EP standards
- Produced and tested according to ISO standard 11133.
- Complete traceability documentation for compliance with BSE/TSE requirements.
- Excellent filterability and solubility reduces preparation time and prolongs filter life during media fills when compared to traditional powdered media, thus saving time and money by reducing filter changes.
- Exclusive granulated format
- Reduction of dust during preparation, lower risk to your operators. Easier handling and less dust to adhere to equipment.
When you are performing a media fill test, the last thing that should be on your mind is if your TSB media is going to affect your validated process.
Every lot Merck Millipore’s irradiated media is tested for Sterility, absence of Mycoplasma, and comes in the high-performing granulated format. Along with the cleanroom ready triple-wrapped packaging, the advantages are clear.
Certificaciones: In compliance with DIN ISO 4796-1 standards.
Información de suministro: Supplied with screw cap and pouring ring.
Envase: The bottles are packaged in shrinked-wrapped modules.
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