Isolator Servicing

Isolators should be serviced and requalified at least every six months. GMP Annex 1 (C(2022) 5938 final) sets a maximum six-month interval for requalifying Grade A zones.

QAAPS (5th edition) applies the same expectation to aseptic preparation units. We schedule visits around your production runs and planned shutdowns to minimise downtime.

An isolator service checks electrical function and unit condition, and replaces consumable parts. Engineers calibrate the digital depression and flow gauges, then set operating conditions and differential pressures.

Testing covers pressure and flow monitoring, the classification leak test, inlet filter particle counts, breach velocity through the glove ports and an inlet filter aerosol challenge. Every visit ends with a summary service report.

Customers will receive a comprehensive service or validation report documenting all testing carried out along with the methods used to calculate results and workings. This is provided back to the customer as the original paper documents, wet signed and dated in the DD-MM-YYYY format.

When provided in this format the documents remain compliant to MHRA audit standards making them suitable for internal processes.