PHARMA KING ACE

Environmental Conditions in Pharmaceutical Industry During Manufacturing Maintaining strict environmental conditions is critical in pharmaceutical manufacturing to ensure quality, safety, and compliance. Each dosage form and drug type — beta-lactams, non-beta-lactams, liquids, and injections — has specific environmental, temperature, and humidity requirements. Below is a detailed area-wise overview. 1. Environmental Control in Beta-lactam Manufacturing Why? Beta-lactams (penicillins, cephalosporins, carbapenems) are allergenic and degrade rapidly under moisture. They must be produced in segregated, dedicated facilities. Key Environmental Conditions: Facility: Independent building with separate AHU. Air classification: General manufacturing → ISO Class 8 (Grade D) Critical operations (dispensing, filling, milling) → ISO Class 7 (Grade C) Temperature limit: 18–25°C (best practice ~22°C). Relative Humidity (RH) limit: ≤40–50% (best practice 35–40%) to reduce hydrolysis. Pressure different...

HVAC Validation in Pharmaceutical Industry – A Complete Guide Introduction In pharmaceutical manufacturing, maintaining a controlled environment is crucial for product quality and patient safety. Heating, Ventilation, and Air Conditioning (HVAC) systems play a vital role in ensuring controlled temperature, humidity, air quality, and cleanliness. To comply with regulatory requirements (US FDA, EU GMP, WHO), HVAC systems must undergo a rigorous validation process that demonstrates their reliability and effectiveness. What is HVAC Validation? HVAC Validation is the documented process of proving that the installed HVAC system performs consistently as designed, maintains cleanroom classifications, and prevents contamination in manufacturing areas (especially in OSD, Sterile, and Biotech facilities). It covers: Design Qualification (DQ) – Ensuring system design meets GMP requirements. Installation Qualification (IQ) – Verifying correct installation of AHUs, ducts, HEPA filters, sensors, etc....