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Sterile Products
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Sterile Products

Injectables

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

Injectables are produced in sterile environments, GMP Grade A. Most appropriately excluding of direct contact from the working personnel must be provided and preparation and filling shall be 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 of an isolator Grade A is also clean and can be Grade C to Grade D.

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.

Orals

Orals production does not frequently require sterile environment, GRADE D (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.

What we offer in Pharmaceutical suits 

V. Bougatsos SA has special knowhow on the needs of pharmaceutical facilities and can assist customers from initial design to turnkey execution of a new production line, an expansion or a refurbishment undertaking construction of the cleanroom, design and installation of all the HVAC equipment and cleanroom certification. All materials and equipment provided are of well known international manufacturers all accompanied with certificates of compliance for cleanrooms and certificates of calibration.

If required V. Bougatsos SA can follow a clean build protocol assuring that all installed equipment is dust free and no dust is produced and deposited in the cleanroom elements during construction.

V. Bougatsos SA 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 V. Bougatsos SA provides Design Qualification (DQ) and Installation Qualification (IQ) Certificates.



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