Vaccine production processes have special sterility and biocontainment
requirements which often oppose one another. cGMP is based on the concept of keeping contaminants out, whilst biocontainment
is based on the concept of keeping product in. Live virus Vaccines cannot be sterilised by heat treatment because it would
kill the virus, whilst filter sterilisation is not possible due to the large size of the virus. Consequently, sterility can
only be ensured if the entire production process is completely sterile.
Under-design
results in the
failure of the product.
Vaccine manufacturing poses many challenges to ensure both personnel
safety and protection of the environment. PACE Pharma Services have the necessary skills in containment and waste management
to satisfy all legal, company and regulatory requirements.
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Over-design can dramatically increase costs.
PACE Pharma Services presents a systematic methodology for
the project management of Vaccine manufacturing processes, which includes the associated equipment and the integration of
the preliminary design, detailed design, construction and validation phases of a project to minimise the challenges, and cost
and schedule overruns typically associated with implementing these complex processes.
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