Cleanroom

FAVEA has been designing and producing cleanrooms for over 15 years, safeguarding pharmaceutical production that requires targeted solutions for production in atmospheres where contamination is kept under control. FAVEA employes latest technologies and modern systems for the distribution of air and for controlling contamination able to satisfy the strictest standards on cleanliness, hygiene safety and quality.

The most recent set of standards for Europe has come into operation on the 1 January 1997. This is contained in a 'Revision of the Annexe to the EU Guide to Good Manufacturing Practice-Manufacture of Sterile Medicinal Products'.

The following is an extract of the information in the standard that is relevant to the design of cleanrooms:

The manufacture of sterile products should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for equipment and materials. Clean areas should be maintained to an appropriate cleanliness standard and supplied with air which has passed through filters of an appropriate efficiency.

The various operations of component preparation, product preparation and filling should be carried out in separate areas within the clean area. Manufacturing operations are divided into two categories; firstly those where the product is terminally sterilised, and secondly those which are conducted aseptically at some or all stages.

Clean areas for the manufacture of sterile products are classified according to the required characteristics of the environment. Each manufacturing operation required an appropriate environmental cleanliness level in the operational state in order to minimise the risks of particulate or microbial contamination of the product or materials being handled.

In order to meet "in operation" conditions these areas should be designed to reach certain specified air-cleanliness levels in the "at rest" occupancy state. The "at-rest" state is the condition where the installation is complete with production equipment installed and operating but with no operating personnel present. The "in operation" state is the condition where the installation is functioning in the defined operating mode with the specified number of personnel working.

For the manufacture of sterile medicinal products normally 4 grades can be distinguished.

Grade A: The local zone for high risk operations, e.g. filling zone, stopper bowls, open ampoules and vials, making aseptic connections. Normally such conditions are provided by a laminar air flow work station. Laminar air flow systems should provide an homogeneous air speed of 0.45 m/s +/- 20% (guidance value) at the working position.

Grade B: In case of aseptic preparation and filling, the background environment for grade A zone.

Grades C and D: Clean areas for carrying out less critical stages in the manufacture of sterile products.