Pharmaceutical Manufacturer Solves Contamination Problem

April 10, 2007

Challenge

“Our manufacturing area of this facility sees a steady flow of traffic, with material handling, packaging and product moving in and out of a series of mixing rooms,” stated the Vice-President of Engineering at a leading pharmaceutical manufacturer.

Room separation was an important consideration in the layout of this facility, which compounds pharmaceuticals for a variety of private labels.  Each area has to be isolated to avoid contamination of the product between the rooms.  A twelve foot wide hallway connects the rooms and leads to the warehouse...another source of contamination.

Compliance with FDA guidelines for current Good Manufacturing Practices (CGMP), which specifies an optimal environment for both product and the employees, was also a major concern.  These guidelines establish the amount of airborne particles allowed in order to control contamination within an area. 

The current doors that separated these rooms were constantly being hit as workers slammed their way through to keep up with the brisk pace of work.  The significant amount of maintenance required to keep these doors operational was becoming excessive and costly.  Despite all efforts, these doors invariably ended up sagging on their hinges from the continuous pounding.

Not only was the damage a concern, but the increased risk of contamination from airborne chemicals passing through the gaps from one room to the next was an important issue.  With the air flow levels and negative pressures in the hallway between the rooms, particles can travel easily and threaten the quality of the controlled substances manufactured at this facility.

Solution

After seriously evaluating several other door options, the facilities manager chose the CleanSeal® door system. “In our operation, we need a heavy-duty, easy-to-clean door that gets out of the way of our heavy traffic”, stated the manager.  “We took the time to visit several facilities that had cleanroom doors and chose CleanSeal because of their features and design.” This facility installed 40 doors, single slide and bi-parting, manual and powered.  Almost immediately, the manager reported how the personnel liked the ease with which they could travel from one room to the next.  The doors open and close quickly providing the tightly controlled environment needed here. They clean easily and withstand bumps from carts without damage.

The CleanSeal design provides a door where dirt can’t hide and contamination has no place to enter.  With its specially designed gasket, it maintains a full seal under the negative pressures found in the hallway. And, it features an easy adjustment for tight or loose sealing.

“The FDA will be extremely pleased with these new doors”, stated the manager. We are very happy as our repair costs have been eliminated and our productivity has increased.