Manufacturing standards

Biochrom AG offers highest quality and competitive pricing at the same time; all manufacturing processes and strict quality systems enable and guarantee low endotoxin levels for liquid bulk products. Biochrom follows Good Manufacturing Practice (GMP) guidelines: this requires validation, and documentation of all operational procedures, systems, functions, facilities, materials, and equipment. Products are prepared by an aseptic process for which each step has been validated to ensure that all liquids do meet the highest standards.

Biochrom AG has established Standard Operating Procedures (SOPs) for all its manufacturing and quality procedures. The company validates its equipment and processes on a regular level to ensure that they meet specific designed criteria in adaptation to internal and external quality assurance. Audits are performed to verify that manufacturing and quality control functions are being properly executed.


Sterile Process Liquids, Buffers and Balanced Salts from Biochrom AG

Rapid advances in biopharmaceutical production have created a growing need for reliable sources of sterile process liquids delivered ‘just in time’. Biochrom’s production of bulk sterile liquids is based on its source of highly purified water, that does meet the Water for Injection (‘WFI’) criteria. All commonly used buffers, balanced salts and cell culture media are available according to customer’s own specifications, manufactured under GMP, and ISO 9001 guidelines. Production incorporate a rigorous specification and approval process that includes screening of all incoming related raw material, this specifies Ph.Eur. grade components, and/or components of non-animal origin.

All Biochrom AG process liquids are intensively tested prior to QC release, and packed in containers ranging from 100, 500 and 1000 ml PET-bottles, 100 ml to 50 ltrs media bags or larger volumes of 200, 500 and 1000 ltrs media bags, shipped in appropriate stainless steel containers.

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Certificates

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The ISO 9001/2000 certification: a further step in quality management for Biochrom AG.

download ISO-Certificate
download ISO-NET-Certificate