Grade D packaging

Pharmaceutical

21°C / 45% RH ±10%

1,050m2

THE CLIENT

A newly formed UK based Pharmaceutical manufacturing company producing generic drugs on a large scale that serve a wide range of therapeutics for the worldwide market. Additionally providing a variety of services from IP Licensing to Manufacturing to R&D.

THE BRIEF

After delivering a suite of cleanrooms for the owner of a generic Pharmaceuticals company, Guardtech were commissioned to design and construct a large-scale manufacturing facility. Phase two of this project was the construction of Grade D cleanrooms to house separate blister packaging lines for bulk packaging of a number of different pharmaceutical products.

“One of the notes made by the inspector was that this was as good a facility as he has been in, which is indicative of your team’s hard work and quality of work.”

Operations Director, Noumed Life Sciences

THE TECH SPECS

A controlled environment designed, installed, cleaned and commissioned by Guardtech built to the following specification:

Structural: GT Shell Plus PIR Wall Panels, GT Lid Max PIR Ceiling Panels, GT Shell Lite Wall Cladding, GT Access Pro GRP Doors, GT Deck Plus Vinyl Floor Capped & Coved, GT Lid Lite Powder Coated Aluminium Ceiling Grid & PVC Tiles.

Electrical: 13-amp & 3Ph Power and Cat 5e Network flush mounted sockets, containment buried within the wall panels in channels and housed in basket in service channels in the ceiling void.

Mechanical: Separate bespoke AHUs serving each packaging line, laydown and sampling areas served by a chiller with a shared AHU for common areas. Compressed Air pipework, Process Chilled Water, Central Vacuum System.

Monitoring: GT Scan Max CF21R compliant Environmental Monitoring System with in-room displays, alarm beacons and software . BMS connectivity For all plant and services.

Furniture: Bespoke Trespa Workbenches with integrated Shelving and Sinks, Trespa Cabinets, Stainless Steel Utility Sinks, Chemical Storage Cupboards, Roller Racking.

THE CHALLENGES

The Floor: A resin floor was required – however, the area that was to be covered extended over two separate slabs. Extensive surveys and core samples were required to determine the type of slab and the most appropriate substrate to overlay, which was eventually specified as a high build two-part epoxy resin with quartz and sand mesh base layer.

Automatic Doors: Programming the logic between the manual and automatic doors and their interlocking function was a time consuming and difficult exercise.

HVAC balancing: Each of the process rooms were designed at a high pressure and are served by a common central corridor – this, along with the use of calibrated weighted Pressure Relief Valves (PRVs), meant that balancing was a very delicate exercise that required a great deal of care and technical skill. 

Heat exchanger: A heat exchanger was required to stop the pipes from freezing, so this was installed to provide two loops – one glycol-enriched to prevent pipework freezing and the other with H2O only serving the process equipment.

THE RESULT

“I am happy to inform you that our MHRA inspection went very well over this past week. The site successfully passed its inspection for Packaging, Warehouse and QC Testing. We expect to receive formal certification in the next 45 days. 

“One of the notes made by the inspector was that this was as good a facility as he has been in, which is indicative of your team’s hard work and quality of work. For that I would like to thank you both and your teams. It only means that the standard has been set high for our next project together which will be in the very near future.”

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