The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies can deal in generic and/or brand medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs.
Drug discovery and development is expensive; of all compounds investigated for use in humans only a small fraction are eventually approved. This approval comes only after heavy investment in pre-clinical development and clinical trials, as well as a commitment to ongoing safety monitoring. Biopharmaceuticals are 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.
There is a trend toward Biopharmaceuticals (as opposed to traditional small molecules produced by chemistry techniques) due to the potential specificity and potency against a target disease. However biopharmaceutical processes require greater application of Aseptic processing and the associated environmental controls and monitoring to ensure this is achieved.
The traditional use of HPV decontamination technology for Isolators in the Pharmaceutical industry is now extending to Room scale decontamination, Materials transfers and process equipment bio-decontamination. The ability to manage safety at room scale whilst achieving 6 log sporicidal efficacy has been a significant development to improve decontamination assurance over more manual processes.
The use of biological indicator challenges (6-log reduction of Geobacillus stearothermophilus) to validate, monitor and re-qualify decontamination cycles together with other process data provides the necessary GMP compliance evidence.
Recovery for Shutdown or commissioning using a HPV facility decontamination cycle provides a rapid and assured routine for restart under required micro-biologically controlled conditions.
Also the control of bio-burden in controlled areas where in response to deviation or as a process requirement to reduce risk of compromise of closed processes that may include intervents hence are at risk is another good use of the technology.
One essential requirement for take up of this HPV technology is the material and process compatibility requirements. Research and practice demonstrate fully manageable compatibility with a very broad range of excellent compatibilities of some very sensitive equipment.
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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