HVAC Validation

HVAC Failures in FDA Inspections: Lessons Learned

HVAC Failures in FDA Inspections: Lessons Learned HVAC Failures in FDA Inspections: Lessons Learned The pharmaceutical industry faces strict regulatory standards to ensure product quality and patient safety. Among the critical systems that support manufacturing processes, Heating, Ventilation, and Air…

HVAC Validation for Grade A/B Cleanrooms: EU GMP Expectations

HVAC Validation for Grade A/B Cleanrooms: EU GMP Expectations HVAC Validation for Grade A/B Cleanrooms: EU GMP Expectations In the highly regulated pharmaceutical environment, validation of HVAC systems for Grade A/B cleanrooms is essential to ensure product quality and compliance…

How to Qualify HVAC in Aseptic and Oral Facilities Differently

How to Qualify HVAC in Aseptic and Oral Facilities Differently How to Qualify HVAC in Aseptic and Oral Facilities Differently In the pharmaceutical and biotechnology industries, HVAC systems play a critical role in maintaining the quality and integrity of products.…

Designing HVAC Systems for GMP Compliance: A Step-by-Step Guide

Designing HVAC Systems for GMP Compliance: A Step-by-Step Guide Designing HVAC Systems for GMP Compliance: A Step-by-Step Guide Step 1: Understanding User Requirements Specifications (URS) & Risk Assessment Designing HVAC systems for GMP compliance begins with a clear formulation of…

Room Classification Standards for Pharma HVAC Systems (ISO 14644, EU GMP)

Room Classification Standards for Pharma HVAC Systems (ISO 14644, EU GMP) Room Classification Standards for Pharma HVAC Systems (ISO 14644, EU GMP) In the pharmaceutical industry, maintaining controlled environments is essential for ensuring product quality and compliance with regulatory requirements.…

Cleanroom Design: HVAC Zoning, Pressure Cascade, and Airflow

Cleanroom Design: HVAC Zoning, Pressure Cascade, and Airflow Cleanroom Design: HVAC Zoning, Pressure Cascade, and Airflow In pharmaceutical manufacturing, maintaining a controlled environment is crucial for product quality and compliance with regulatory standards. The validation of HVAC systems in cleanrooms…

Class 100,000 vs ISO Class 7 vs Grade C: What’s the Difference?

Class 100,000 vs ISO Class 7 vs Grade C: What’s the Difference? Class 100,000 vs ISO Class 7 vs Grade C: What’s the Difference? In the pharmaceuticals and biotechnology sectors, maintaining appropriate environmental conditions is imperative not only for ensuring…

Designing HVAC for Non-Sterile vs Sterile Areas

Designing HVAC for Non-Sterile vs Sterile Areas Designing HVAC for Non-Sterile vs Sterile Areas This article provides a comprehensive, step-by-step tutorial on the validation of HVAC systems used in sterile and non-sterile environments, focusing on the compliance requirements outlined in…

Components of a Pharmaceutical HVAC System and Their Functions

Components of a Pharmaceutical HVAC System and Their Functions Components of a Pharmaceutical HVAC System and Their Functions This article serves as a comprehensive guide for pharmaceutical professionals focusing on the validation lifecycle of HVAC systems within pharmaceutical manufacturing environments.…

Planning HVAC for API Manufacturing Facilities

Planning HVAC for API Manufacturing Facilities Planning HVAC for API Manufacturing Facilities Environmental control is paramount in Active Pharmaceutical Ingredient (API) manufacturing. The Heating, Ventilation, and Air Conditioning (HVAC) system plays a crucial role in ensuring that the facility meets…