1The Challenge
A contract pharmaceutical manufacturer needed to create a new GDP-compliant temperature-controlled storage zone within their existing licensed warehouse, maintaining 15–25 °C with logged evidence of compliance for regulatory purposes. The zone needed to accommodate 4 metres of racking and a pallet truck access point. The installation had to be compatible with the facility's GMP change control process and produce documentation suitable for inclusion in the site's validated state.
2Our Solution
Mercia Industrial designed and installed a ThermalShield insulated enclosure with 75 mm panels, delivering the required thermal performance to maintain 15–25 °C across all anticipated ambient conditions. The access point was fitted with a double-overlap PVC strip curtain using pharmaceutical-grade strips with documented material specification. Mercia provided a comprehensive installation qualification package including design documentation, as-built drawings, material certifications, and a performance test report from the initial temperature mapping exercise.
3The Outcome
The zone passed the client's Installation Qualification (IQ) and Operational Qualification (OQ) protocols without any deficiencies. Temperature mapping across 9 monitoring points over a 72-hour period confirmed that the zone maintained the target range of 15–25 °C under both summer and winter ambient conditions. The zone has now been in validated service for 18 months without requiring any maintenance interventions.
“The IQ/OQ documentation package that Mercia provided was exactly what our QA team required — comprehensive, accurate, and presented in a format that slotted directly into our validation master plan. The zone itself has performed flawlessly.”
— QA Director, Contract Pharmaceutical Manufacturer, Nottingham
- Client
- Pharmaceutical Manufacturing Nottingham
- Location
- Nottingham, Nottinghamshire
- Industry
- Pharmaceutical Manufacturing
- Product
- ThermalShield