Asgard have designed and constructed cleanrooms (controlled contamination environments – GxP) for all aspects of pharmaceutical & biological sectors, from clinical trial to pilot scale facilities, research, and development through to small / medium & large-scale manufacturing facilities. Confidence can be gained from our extensive experience and proven track record of providing a turnkey solution for small, medium & large-scale manufacturing facilities. Collaborating with our clients, we design controlled environments to achieve our end user’s specification requirements (URS) whilst ensuring the facility meets all regulatory requirements. Asgard are a specialist pharma / biotech cleanroom contractor, where project success is measured, not by achieving practical completion of a none functioning building but the sale of a GMP manufactured product.
Pharmaceutical manufacturing segments today want the most flexible process and facility design possible. Financial planning requires a higher return on investment, and capital funds appropriation (CAPEX). Asgard also understand operational cost demands and importance of operating cost (OPEX) associated with cleanroom energy consumption. We effectively use Annex B of 14644-16, Annex C of ISO 14644-16, ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning, EU GMP, USA FDA aseptic guidance. Asgard employs world leading Subject Matter Experts (SME) to assist all our clients during early-stage feasibility studies, concept design, preliminary design, or basic engineering & detailed design. This could be as basic a peer review by our SME.
All our projects are designed with the following guidance.
- ISO 14644
- US Code of Federal Regulations, Title 21, Food & Drugs
- EU EudraLex