Standard Operating Procedure for Validation of HVAC Systems in Capsule Manufacturing Areas

Department	Capsule Manufacturing
SOP No.	SOP/CM/171/2025
Supersedes	SOP/CM/171/2022
Page No.	Page 1 of 9
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedure for validating HVAC (Heating, Ventilation, and Air Conditioning) systems in capsule manufacturing areas. The HVAC system is critical to maintaining the required environmental conditions (temperature, humidity, airflow, and cleanliness) that support GMP and regulatory compliance. This SOP ensures that the HVAC system operates within acceptable limits, ensuring the quality of the capsules and the safety of the manufacturing environment.

2. Scope

This SOP applies to the validation of HVAC systems in all areas of capsule manufacturing, including production rooms, storage areas, and packaging zones. It covers the process of testing and documenting HVAC system performance against predefined criteria to ensure the system meets regulatory and manufacturing standards.

3. Responsibilities

• Engineering Team: Responsible for installing, maintaining, and setting up the HVAC system in accordance with specifications. They will also perform the installation and operational checks for validation.
• Quality Control (QC) Team: Responsible for conducting the environmental monitoring tests and validating the HVAC system’s compliance with temperature, humidity, and airflow specifications during the performance qualification process.
• Quality Assurance (QA) Team: Reviews and approves the validation process and ensures compliance with GMP and regulatory requirements.
• Production Team: Ensures that the HVAC system is functional during production and that environmental conditions are maintained during the capsule manufacturing process.

4. Accountability

The Engineering Supervisor is responsible for ensuring the HVAC system is correctly installed and operational. The QA Manager is responsible for reviewing the validation results and approving the HVAC system for continued use in production. The Production Supervisor is accountable for ensuring that the HVAC system maintains the required conditions during production runs.

5. Procedure

5.1 Pre-Validation Setup

Before starting the HVAC system validation, ensure the following steps are completed:

1. Review Validation Plan
   1. Review the HVAC system validation plan to ensure it includes all necessary tests, system specifications, and acceptance criteria. The plan should be approved by the QA department before proceeding.
2. System Installation and Setup
   1. Ensure that the HVAC system is installed and set up in the appropriate areas of the capsule manufacturing facility. The system should meet the required specifications for temperature, humidity, and airflow as per the production requirements.
   2. Verify that all equipment is connected to power, air supply, and has no leakage or obstructions.
3. Calibration and System Checks
   1. Calibrate the HVAC system as per the manufacturer’s instructions to ensure accurate temperature, humidity, and airflow measurements. Record calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Performance Qualification (PQ) Testing

Follow these steps to perform the performance qualification of the HVAC system:

1. Verify Temperature Control
   1. Use calibrated thermometers to measure and verify that the HVAC system maintains the required temperature levels in the manufacturing areas. Ensure that the temperature remains stable within the specified limits throughout the test period.
2. Verify Humidity Control
   1. Use calibrated hygrometers to measure and verify that the HVAC system maintains the required humidity levels in the manufacturing areas. Ensure that the humidity stays within the specified range and is stable throughout the test period.
3. Verify Airflow and Air Quality
   1. Verify that the airflow rate is consistent with the specified air changes per hour (ACH) in the manufacturing areas. Check that the system provides adequate air circulation, filtration, and exhaust as required.
4. Test HVAC Response to Load Changes
   1. Simulate load changes (e.g., increase/decrease in personnel, equipment) and verify that the HVAC system maintains the required environmental conditions in response to those changes.
5. Test Alarm Systems
   1. Test the alarm systems to ensure they activate when the temperature, humidity, or airflow fall outside of the acceptable range. Ensure the system generates appropriate alarms for deviations.
6. Document PQ Results
   1. Document the results of all performance tests. If any deviations are found, investigate the causes and take corrective actions. Re-test the system until all performance criteria are met. Record the results in the PQ Log (Annexure 2).

5.3 Post-Qualification Activities

After successful completion of the PQ process, ensure the following tasks are completed:

1. System Integration into Production
   1. Once the HVAC system passes all PQ tests, integrate the system into regular production operations. Ensure that the system maintains the required conditions during production runs.
2. Operator Training
   1. Train operators and maintenance personnel on the proper operation, monitoring, and troubleshooting of the HVAC system, including how to handle alarm events and perform corrective actions.
3. Sign-Off and Approval
   1. Ensure that the PQ process is successfully completed, and the HVAC system is signed off by the QA Manager. The PQ Report should be approved and filed for record-keeping.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• PQ: Performance Qualification
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment

7. Documents

1. Annexure 1: Equipment Calibration Log
2. Annexure 2: Performance Qualification Log
3. Annexure 3: Performance Qualification Report

8. References

• FDA Guidelines on HVAC System Performance Qualification
• Good Manufacturing Practice (GMP) Guidelines
• USP <797> – Pharmaceutical Compounding – Sterile Preparations

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Equipment Calibration Log

Equipment ID	Calibration Date	Operator	Calibration Details	Next Calibration Due
HVAC System 105	01/02/2025	John Doe	Calibration of temperature, humidity, and airflow sensors	01/02/2026

Annexure 2: Performance Qualification Log

Batch ID	PQ Date	Operator	Test Type	Results
Batch 001	02/02/2025	Jane Smith	Temperature Test	Pass

Annexure 3: Performance Qualification Report

Batch ID	Test Date	Test Type	Results	Remarks
Batch 001	02/02/2025	HVAC Performance Test	Pass	HVAC system maintained stable temperature and humidity

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for HVAC system validation in capsule manufacturing	QA Head
01/02/2025	2.0	Updated testing parameters and added new validation criteria	Improvement of system validation tests and expansion of coverage	QA Head