KIMTECH A5 Cleanroom Garment System Aligns with EU GMP Annex 1

Bio contamination is generated by live particles from human activity – bacteria, yeast, mould, viruses. KIMTECH A5 has Clean don Technology, a flexible head to toe solution for compliant sterile donning.

Draft Annex 1 Compliance

“Garments should be packed and folded in such a way to allow operators to change into garment with contact to outer garment reduced as a minimum.”

The A5 garments have features to ensure the above guideline is addressed, such as blue line, inside out donning and snap release.

Compliance with aseptic gowning procedures should be assessed.

Risk of sterility assurance

• High vacuum packing (or Heavy vacuum compressed packaging) – product should be stiff
• Guarantees sterility (SAL 10-6)

Risk of contamination during donning

• Package folding system

Risk of contamination in operations

• Quality by design, meaning few gaps reducing bacteria contamination from the operator
• Improved fit and comfort in aseptic operations, elasticated round the back waist area

Change Management Support

We understand that change must be validated, so we provide support and guidance through the Change Management Process.

• A – Alignment of stakeholders / key decision makers
• P – Project Management - timeline and implementation of the product into your process.
• E – Engagement & Training – ongoing training and assistance offered to your teams through regular sessions
• X – Exceptional Workplace – Adding value to your workplace

Donning tips

• Once in the gown, cross legs (increase garment tension), then pull the zip up.
• Ballet feet – pointy toes when donning
• A5 garment is not laminated making the garment more breathable