The second of ASHRAE Irelands technical symposium series events took place in Cork Institute of Technology on May 10th at 06:30PM. The event entitled “Refrigeration and HVAC control in the bio pharmaceutical industry” welcomed and audience of over to 40 people taking into account both online and general attendees. Two presentations were made at the evening event; one by Liam Crowe from PM Group and one by Pauline Sourdille from Sirus Building Solutions. Both talks tied together the complicated bio-pharmaceutical industry in Ireland, highlighting regulations and controls from the transportation, manufacturing and to the maintenance of the facilities used in the industry.
Liam gave an overview comparison between a Biopharmaceutical facility and an Active Pharmaceutical Ingredient (API) bulk pharmaceutical plant. The variation in low temperature requirement were presented and he clearly indicated the importance of the coordinated design effort and traceability of design criteria from concept initiation right through to final commissioning and handover. In his presentation, Liam portrayed a regulatory chain that was quite complicated where the documentation costs are quite high and are considered vital to the entire process of making and shipping pharmaceuticals.
Pauline emphasised the importance of bringing design commissioning requirement and validation forward to be an inclusion part of a project initial concept design. This activity should not be a silo tacked on to the end of a construction phase. She provided a design overview of various Cleanroom classifications and a comparison between US and EU standards and also indicated the importance of identifying client design criteria for Cleanliness level, Room temperature, relative humidity, Room pressure and Air flow pattern prior to commencement of design calculations. She clearly indicated that meeting a client agreed design criteria during the on site commissioning stage was a critical determinant for completion of validation protocols sign off within agreed client tolerances to successfully hand over a project to ensure fitness for purpose to allow pharmaceutical production manufacturing commence within the strict regulatory framework within which it operates.
- Liam Crowe (PM Group): Refrigeration in the Biotech Industry
- Pauline Sourdille (Sirus Group): HVAC Control System Requirements for the Biotech Industry