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Vaccines and Pills

Vaccines

Vaccines & Injectables production is the most demanding pharmaceutical process and requires the highest quality environmental conditions.

Vaccines are produced in sterile environments, class 100 (ISO 5), excluding direct contact with the working personnel. Preparation and filling is carried out in isolators. In some products negative overpressure is implemented in the isolator in order to assure no product outflow and contact with the humans in case of a leakage.  The surrounding environment is also clean and can be from class 100.000 to 10.000.

Injectables which contain water solution require also sterile conditions and are produced and packed in isolators.

Injectables which are in powered form, such as antibiotics, require low relative humidity 25% to assure constant product flow.

Also these products produce clouds of particles while flowing to the filling machines constituting a great hazard towards the working personnel and contaminating other pharmaceutical products which are produced in the same pharmaceutical suite (cross contamination). For these reasons special extraction equipment is necessary with HEPA filtration on the air outlet to the environment, or the implementation of isolators and containment cabinets and also the isolation of the production line away to other products facilities.

Pills

Pills production does not frequently require sterile environment, class 100.000 (ISO 8) is often sufficient. Pills production mainly encompasses the risk of cross contamination. For this reason proper control of the air movement achieved by proper implementation of the necessary overpressures as well as effective exhaust of the airborne dust from pharmaceutical substances at the spots where it is produced (filling machines etc.) are indispensable.

Frigomech has special knowhow on the needs of pharmaceutical facilities and can assist customers from the initial design to providing turnkey solutions for a new production line, an expansion or a refurbishment.

Frigomech can also offer pharmaceutical suites validation and perform all the necessary measurements and balances to provide Operation Qualification (OQ) and Performance Qualification (PQ) Certificates, prepare the necessary documentation and assist customers in audits with the official GMP authorities. In new projects Frigomech provides Design Qualification (DQ) and Installation Qualification (IQ) Certificates.



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