HVAC Validation

Key Differences in HVAC Requirements for Oral vs Injectable Units

Key Differences in HVAC Requirements for Oral vs Injectable Units Key Differences in HVAC Requirements for Oral vs Injectable Units In the pharmaceutical industry, the design and validation of Heating, Ventilation, and Air Conditioning (HVAC) systems are critical for ensuring…

Regulatory Requirements for HVAC Design (FDA, WHO, EMA)

Regulatory Requirements for HVAC Design (FDA, WHO, EMA) Regulatory Requirements for HVAC Design: A Step-by-Step Validation Tutorial In the pharmaceutical and biotechnology industries, an appropriately designed Heating, Ventilation, and Air Conditioning (HVAC) system is critical to maintaining product quality and…

Building Management System (BMS) Integration with HVAC

Building Management System (BMS) Integration with HVAC Building Management System (BMS) Integration with HVAC This article serves as a comprehensive guide for pharmaceutical professionals focused on the essential processes of validation in HVAC systems. It provides detailed steps aligned with…

Setting Up Differential Pressure and Air Change Rate Parameters

Setting Up Differential Pressure and Air Change Rate Parameters Setting Up Differential Pressure and Air Change Rate Parameters Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first critical step in the validation lifecycle involves the creation of…

How to Select Filters: HEPA, ULPA, and Pre-Filters for HVAC

How to Select Filters: HEPA, ULPA, and Pre-Filters for HVAC How to Select Filters: HEPA, ULPA, and Pre-Filters for HVAC Step 1: Understanding User Requirements Specification (URS) & Risk Assessment The foundation of any validation lifecycle begins with a clear…

Classification Requirements for Support Areas and Material Transfer Zones

Classification Requirements for Support Areas and Material Transfer Zones Classification Requirements for Support Areas and Material Transfer Zones In the pharmaceutical and biologics industries, maintaining a controlled environment is paramount to ensuring product quality and regulatory compliance. The classification of…

Sample HVAC Layout Plans for Grade A to D Areas

Sample HVAC Layout Plans for Grade A to D Areas Sample HVAC Layout Plans for Grade A to D Areas The design, validation, and continued assurance of HVAC systems used in pharmaceutical manufacturing are critical components in ensuring compliance with…

Risk-Based Approach to HVAC Design for New Facilities

Risk-Based Approach to HVAC Design for New Facilities Risk-Based Approach to HVAC Design for New Facilities In the pharmaceutical and biologics industries, maintaining a controlled environment is paramount for compliance with regulatory standards and for ensuring product quality. The HVAC…

Role of Return Air Risers and Terminal Filters in Cleanroom Control

Role of Return Air Risers and Terminal Filters in Cleanroom Control Role of Return Air Risers and Terminal Filters in Cleanroom Control Ensuring a controlled environment within cleanrooms is crucial for the pharmaceutical and biopharmaceutical industries. The design and operation…