infochroma's controlled zone for sterile and depyrogenated vials & closures

Since June 2015, infochroma has a controlled zone, where vials and closures may be washed, sterilised, depyrogenated, all according to customer specifications. After moving to larger premises in the summer 2016, we will have a much larger controlled zone so that we can also swiftly produce large series tailored to customer needs.

This we can do:
• Purified water rinse (de-ionised / de-mineralised water)
• packing in low-particle environment
• hot-air sterilisation
• hot-air depyrogenisation
• E-Beam sterilisation in co-operation with contract partners
• individual pack sizes
• individual combination of products per unit
• production of small or large quantities

Quality control
• Validated process
• Skilled staff
• IQ/OQ - equipment qualification, rotative PQ
• Visual inspection for visual defects of 100 % of the finished products
• Analysis for sterility and BET test (bacterial endotoxin-test) carried out by an independent accredited microbiology laboratory
• Detection limit BET: <0.001 EU/ml
• Long term objective: GMP accreditation

Controlled Zone
Introduction
Controlled Zone
Specifications
Work process, equipment
QC & lot specific certificate
Pre-cleaned & silanised
vials for critical applications
© infochroma ag, Chräbelstr. 4, CH-6410 Goldau; Tel: +41 41 748 50 60, info@infochroma.ch