Utilities & Support System Validation

HVAC Qualification in Pharma: Airflow, HEPA Filters & Environmental Control

HVAC Qualification in Pharma: Airflow, HEPA Filters & Environmental Control HVAC Qualification in Pharma: Airflow, HEPA Filters & Environmental Control The HVAC (Heating, Ventilation, and Air Conditioning) system in pharmaceutical manufacturing environments is critical to maintaining cleanroom standards, ensuring product…

Pure Steam & Clean Steam Validation: Quality, Sampling & Testing Guidelines

Pure Steam & Clean Steam Validation: Quality, Sampling & Testing Guidelines Pure Steam & Clean Steam Validation: Quality, Sampling & Testing Guidelines Steam is a critical utility in pharmaceutical manufacturing, especially for sterilization, SIP (Sterilization-in-Place), and cleaning. When steam directly…

Validation of Nitrogen Systems in Sterile & Non-Sterile Pharma Applications

Validation of Nitrogen Systems in Sterile & Non-Sterile Pharma Applications Validation of Nitrogen Systems in Sterile & Non-Sterile Pharma Applications Nitrogen (N₂) is extensively used in pharmaceutical manufacturing for purging, blanketing, conveying powders, and maintaining an inert environment during sensitive…

Validating a Pharmaceutical Water System: RO, PW, WFI

Validating a Pharmaceutical Water System: RO, PW, WFI Validating a Pharmaceutical Water System: RO, PW, WFI Step 1: User Requirements Specification (URS) & Risk Assessment The validation process for a pharmaceutical water system begins with creating a robust User Requirements…

Microbial Limits and Alert Levels for PW and WFI

Microbial Limits and Alert Levels for PW and WFI Microbial Limits and Alert Levels for PW and WFI As pharmaceutical manufacturing processes increasingly rely on purified water systems, understanding microbial limits and alert levels for Purified Water (PW) and Water…

Conductivity and TOC Testing in Water System Validation

Conductivity and TOC Testing in Water System Validation Conductivity and TOC Testing in Water System Validation Water systems play a crucial role in pharmaceutical manufacturing, where the quality of water directly impacts the safety and efficacy of the final products.…

Sampling Plan for Pharmaceutical Water Systems: Best Practices

Sampling Plan for Pharmaceutical Water Systems: Best Practices Sampling Plan for Pharmaceutical Water Systems: Best Practices In the production of pharmaceuticals, water systems serve as critical utilities that support various processes, including formulation, cleaning, and equipment rinsing. Therefore, ensuring the…