Gowning

A major percentage of clean room excursions are due to contaminants of human origin. Thus it is not an overstatement to say that Gowning(Primary and Secondary) is probably the most important factor of any Contamination Control Strategy{CCS}.

The Primary/Factory garment is hugely underrated in industry. It is important for operator comfort since it is worn close to the skin.It is imperative that this garment be anti-static since it reduces perspiration and itching for the operator which avoids unhygienic behaviour in the clean room.

The anti-static Factory garment as opposed to a 100% polyester garment will also ensure a lower non-viable particle count which is essential in injectable manufacturing.100% polyester garments generate a static charge which attracts non-viable particles thereby increasing particle loads in the clean areas.

As mentioned in the revised EU Annex 1 the CCS needs to have a holistic approach and the Factory garment is a good place to start.

The Secondary gown is the most critical barrier between the human and the clean room environment. The design of the Secondary gown must be such that it keeps the particles generated by the human body within the barrier of the gown while still allowing enough air and water vapour permeability to keep the operator comfortable. Not only the fabric chosen should meet the critical balance required but it must also be stitched according to the IEST RP0003.4 standards for gowning design.

Gowning features should include but are not limited to:

-Heat sealed/fused edges after cutting

-Lapped seams with double needle stitching

-Raglan sleeves

-Antistatic grid

-High Filteration efficiencies for the fabric for 0.3 micron and 0.5 micron particles. Usually these should be in the high 90 percentage range.

-Good water vapour and air permeability inspite of high filteration efficiencies

-Antistatic bootie soles.