GMP Word of the Week - Cleanroom Pressure Differentials
By: Greg Weilersbacher, EQC Founder & President | 5-min read
Differential Pressure – A dissimilarity in air pressure between one cleanroom and adjacent cleanrooms, hallways, air locks, and pass-throughs created by a difference in air velocity/air volume and mechanical means of limiting air transfer from one area to the next.
Why it Matters – Regulatory agencies require pharmaceutical products to be manufactured and primary-packaged in cleanroom classifications suitable for the dosage form.
- Positive pressure differential: Air pressure inside the cleanroom is greater than adjacent areas to prevent contaminants from entering the cleanroom.
- Negative pressure differential: Air pressure inside the cleanroom is less than outer areas to prevent harmful compounds inside the cleanroom from escaping.
Case Study – A GMP audit was performed of a packaging facility used by a client for several years to package their products into primary containers. The audit began with a facility tour where the auditor was led through cleanroom hallways, air locks and primary packaging rooms. The auditor noticed that the cleanroom complex did not use magnahelic gauges (analog or digital) to measure the air pressure differential between the cleanrooms and adjacent areas. The facility’s manager confirmed that although air pressure differentials were being electronically monitored production personnel would not be notified if the air pressure dropped below specifications.
Upon returning to the audit room, the auditor inspected the cleanroom HVAC (i.e., Heating, Ventilation, and Air Conditioning) validation records. These records showed that there were no air pressure differentials between any any rooms in the cleanroom complex. The auditor then requested the air pressure monitoring records for the last 12 months and discovered that the air pressures differentials throughout the cleanroom complex were at zero for the entire year. When the client was notified of this serious problem she immediately halted her company’s plans for the next packaging run and demanded that the packaging company perform a product impact assessment.
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References
- 21 CFR 211.46 Ventilation, Air Filtration, Air Heating and Cooling
- ISO 14644-1:2015 Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness By Particulate Concentration
- World Health Organization, Annex 6 WHO Good Manufacturing Practices for Sterile Pharmaceutical Products
About the Author: Greg Weilersbacher is the founder and president of Eastlake Quality Consulting (EQC), a GMP consulting firm. Over the last 27 years, he has held senior leadership positions leading quality assurance, quality control, analytical chemistry, materials management, GMP facilities, and product manufacturing in biotech and pharmaceutical companies.
Questions or Inquiries?
Eastlake Quality Consulting (EQC) can provide support in the areas of quality assurance, quality control, and manufacturing operations. We also offer training on GMP requirements and can assist with the development of policies and procedures. EQC is your partner for compliance with good manufacturing practices.
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