Designing concepts for pharmaceuticals manufacturers

Designing concepts for pharmaceuticals manufacturers

45 ASSA ABLOY Entrance Systems Albany high-performance doors, including Albany RR300 Clean doors for controlled areas were specified for a pharmaceutical company.

Background

When a leading supplier of Pharmaceutical and Bio-technological products investigated solutions for a brand new, custom-built production facility in Ireland, designers working on the cleanroom and controlled environment concepts looked to high performance doors for operational excellence. Owing to the sensitive nature of pharmaceutical production, entrance systems manufacturers were consulted pre-design in order to achieve specific ISO standards and GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice) and GDP (Good Distribution Practice) compliance.

Challenge

Consultants were asked to provide solutions to meet stringent legislation and HVAC standards for designated cleanrooms. Suppliers were challenged to demonstrate resistance to the often significant positive and negative air pressures used in such facilities, to repel particulates.

Requirements

• Easy to clean.
• Resistance to denigrating effects of aggressive cleaning agents used in Pharmaceutical production facilities.
• Potential ill-effects created by collisions between MHE and door frames/curtains.
• Interlocking options; used as an additional guard against particle ingress/egress.
• Demonstrate the reliability of door automation solutions.
• Ability to withstand adverse effects associated with HVAC pressures.

A concept design was agreed for an easy to clean fabric curtain with stainless steel frame to meet client needs. ASSA’s specialist consultative approach identified, produced and priced two different solutions, demonstrating the viability of each with a technical submission. By taking previous experiences from other sites around the globe, their white paper identified ways the client could design-out historic problems.

Solutions

ASSA ABLOY Entrance Systems specialists consulted the end user directly, seeking to understand existing processes. Corporate demands were satisfied after a White Paper was produced demonstrating performance of products and systems against GMP, GLP and GDP when assessed and marked against FDA standards (regulator - USA, promote global standards).

• 45 Albany high-performance doors, including Albany RR300 Clean doors for controlled areas.

Result

Having demonstrated the benefits of solutions designed, manufactured, installed and maintained by ASSA ABLOY Entrance Systems, Albany high-performance doors were specified and ordered by the client.

As a direct result of investigative work performed by ASSA ABLOY Entrance Systems specialists, the client instructed that retrospective modernisation work be performed on door systems used in other, pre-existing facilities situated internationally.

All Albany high-performance door products are air tested, particulate relief tested, CE and UL Marked.

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