While the world may not need one more article about HVAC system qualification, I am going to write this one anyway. There are many opinions written by regulatory and consultants out there, but my hope is that you will find this one easy to read, easy to understand, and based on many years of experience from many sides of the issue. This article is written from my perspective as a former facilities engineer tasked with qualifying these systems and defending them with the regulatory authorities, as Manufacturing VP in a pharmaceutical manufacturing plant, as a VP in an A/E firm that regularly designed HVAC systems in the pharma industry, and as a consultant who has advised my clients on HVAC system qualification.
Back when I started in the pharma industry (and qualification/validation was just getting started), HVAC air handlers were qualified just like a piece of manufacturing equipment. IQ/OQ protocols were written using identical templates, and air handlers were generally treated as stand-alone entities, and not as a true system. Ancillary equipment in the system like boilers, humidifiers, chillers, reheat coils and the like, were either treated as separate pieces of equipment, or they were ignored as being outside the scope of qualification activities.
As time, and qualification sophistication, went on, the pendulum swung in the direction of qualifying everything in the system in one very large and very cumbersome protocol. The problem with this new approach was that, although thorough, if any one thing failed or caused a deviation, the entire protocol could not be signed off, and project timelines were extended. In addition, companies were finding that this approach required significantly more resources that are always in scarce supply. During this time, the industry began to realize that auditors weren’t really interested in every valve and damper in the system and weren’t reviewing these protocols in much detail during audits.
Also about that same time, ASTM E2500 came into use in the industry. ASTM E2500 is a Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. It provides a science (ICH Q8) and risk (ICH Q9) based approach to assure that GMP equipment & systems are fit for use. It applies the concept of critical quality attributes and calls for the use of subject matter experts (SMEs) to make critical determinations, and redefines roles for Quality and Technical SMEs.
On paper, this sounds great, but in practice, the 5 page ASTM document allows for a lot of interpretation and at least in the early days, some users provided risk assessments that were manipulated a bit to show that qualification of HVAC systems wasn’t necessary and they depended entirely on commissioning documents and Good Engineering Practice (GEP) to show that the system was fit for its intended use.
Quality oversight (or lack thereof) during commissioning, also became an issue. Even today, the industry is still struggling with how to leverage the work and documentation done during commissioning in the qualification process (without making it a duplication of the qualification effort), and how to integrate GEP with Good Manufacturing Practice (GMP). It takes a good design team, a good project manager, a good construction team, and an involved quality unit to ensure that the documents produced during design and construction are of sufficient quality and detail to satisfy an auditor.
So what are we to do? The best recommendation for today is to perform a risk assessment following an established method developed by a reputable group like ISPE, WHO, FDA or the EU to determine what parts of the system are direct impact, and which parts are indirect impact. The Direct Impact items get qualified (cGMP), and the Indirect Impact items get commissioned (GEP). Some items (e.g. air balancing) may fall into both categories, and thus will show up in both commissioning and qualification documents.
A word about commissioning. Bringing the air handler’s manufacturers rep out to do a start-up is NOT commissioning. Commissioning will check that the balancing is done according to design, will perform loop checks to make sure communications between the BAS, Air Handling Unit, and control devices (valves, dampers, temperature probes, smoke detectors, etc.) is working properly, and in general whether or not the system is constructed, installed, and working as the designer intended it to work.
Qualification will check that the conditions in the facility that are provided by the HVAC system are as intended including the pressure cascade between rooms, temperature, humidity, filtration, room clean up period, differential pressure, etc. are controlled, recorded, alarmed and performing per the user requirements.
Books could be and have been written on this broad subject, but hopefully, this article will help to answer some of your questions. If you have additional questions, don’t hesitate to contact us.