infochroma's controlled zone

Work process & equipment

Rinsing of the product in the lab washer

The actual cleaning process starts with the rinsing of the products in the lab washer. The products are rinsed with DI-water < 50 µS (deionised, demineralised water). On customer request the rinsing with other DI water values is possible.

 

Packing under LAF

Afterwards the rinsed products are packed in an SBS (sterile barrier system) under LAF (LAF Flow Box).

Thermal process / labelling

The thermal process takes place in the steriliser.

Finally the product is labelled.
The label holds the following information:
• Product number
• Product name
• Pack size
• Lot number
• Production date
• Expiration date

Quality control / lot specific certificate

After the final visual inspection of one hundred per cent of the finished product, samples of each lot are sent to an independent accredited microbiology laboratory, which analyses the samples for sterility and undertakes the BET (bacterial endotoxin test). Only after the laboratory has confirmed that the test results comply with the requirements, the cleaned products held in the quarantine area are released for sales together with a lot specific certificate.

Machine park:
⁃ Miele Mielabor G7783 CD
⁃ KOJAIR CleanWizard V 200
⁃ hawo HM 660 AS-V
⁃ Memmert SF 750 Plus
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