Sack Handling
No cleanroom required
With a closed drying, milling and filling system, manufacturers can now
fill APIs into continuous liners with full GMP compliance
A major international manufacturer of highly potent substances
needed to develop a new method for filling Active Pharmaceutical Ingredients (APIs) whilst avoiding the constraints of a cleanroom.
A study on the elimination of cleanrooms in the filling area, mainly focusing on the improvement of containment, productivity, GMP, quality and product protection was commissioned. The objective was to come up with a pilot project to be applied by the entire group. Following close internal examination a detailed concept based on the manufacturer’s specifications was developed and subsequently submitted to the Drug Administration.
Cleanroom downsides
The maintenance costs for cleanrooms are substantial, not least because of the maintenance and operational procedures needed to keep the cleanroom up to the required standards. Specialised cleanroom garments are essential, with the operator passing through specific locks to put on and take off extensive protection equipment before entering or leaving the cleanroom. The risk to operators’ health must also be taken into consideration, as nitrogen used in cleanrooms can cause Anorexia and similar physical problems. In the US alone several people have died because they have inhaled too much nitrogen. Despite ventilation, the gas accumulates in so-called “nitrogen pockets” which can lead to the asphyxiation of the operator.
GMP compliant filling
The purpose of the project was to allow a contained (<1 µg/m3 )
and GMP compliant filling of APIs without the need of a cleanroom in the filling area. The challenge was to achieve contained and accurate dosing and filling of customised drums from a dryer with a downstream conical sieve mill. The system had to be designed so that both contamination of the powder from the surrounding atmosphere as well as exposure of the
operator was prevented at all times. A comprehensive risk analysis rigorously developed by the customer accompanied the specifications. Following the concept’s presentation to the French Drug Administration, it was sanctioned by AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé). This marked the beginning of the project.
32 Solids & Bulk Handling • May 2010
www.solidsandbulk.co.uk
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