CONTAMINATION CONTROL & MICROBIOLOGY

Overview

We design comprehensive contamination control strategies aligned with EU Annex 1, ensuring sterility assurance and microbial risk control.

Core Deliverables

• Contamination Control Strategy (CCS)

• Environmental monitoring programs

• Aseptic process risk assessments

• Personnel qualification and gowning programs

• Cleanroom behaviour and controls

Regulatory Framework

• EU GMP Annex 1 (2022)

• PIC/S PE009

• ISO 14644

Advanced Capabilities

• Root cause analysis for contamination events

• Trending and statistical monitoring

• Microbial risk modelling

Outcome

Robust contamination control ensuring product safety and regulatory compliance.