The increase in size and scale of bioprocessing presents a challenge as traditional methods of sterilisation such as steam and manual cleaning become increasingly difficult to deploy in large complex production areas in a controlled and regulatory compliant manner.
Biological products are manufactured in complex production lines commonly involving seeding trains, bioreactors and numerous clearing and filtration steps in order to produce the desired final product. Key to the integration of a bio-decontamination methodology is also the need to avoid recontaminating the facility or equipment with additional residues or substances as part of any biodecontamination cycle.
Hydrogen Peroxide Vapour represents a rapid, residue free bio-decontamination technique with efficacy against the broad spectrum potential contaminants. The technique can also be applied as a routine or contamination remediation solution for the challenging areas within a Biotech production facility.
A number of key production steps present opportunities for contamination to be introduced or even cultured alongside the desired cell line. The contamination may be critical to process integrity or may merely reduce cell titre in seeding, however modern in line process monitoring and recording has raised the challenge of maintaining critical parameters across a production line to ensure batch to batch consistency in order to meet increasing levels of regulatory compliance.
Biopharmaceuticals are medical drugs produced using biotechnology. They are proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source.
Emergency outbreak response
Control a ‘superbug’/ Gram-negative/ C.diff/ norovirus outbreak or bio-clean rooms after a contamination accident. Our emergency response teams will professionally bio-decontaminate your areas, returning them to working capacity.
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