Value Delivered
Environmental Specialties collaborated with the client to:
- Address concerns specific to their manufacturing process.
- Advise on installation, operation, and qualification/validation best practices.
- Deliver confidence by administering factory acceptance tests at Environmental Specialties' facility in Raleigh.
Client Objectives
The client needed to produce maximum product yield from their cell culture process by
maintaining tight temperature and CO2 control in fully loaded CO2 incubators. The FDA-regulated environment the client operated in also required the incubators to be qualified
and validated under these fully loaded conditions. The client had been trying to qualify a
competitor’s CO2 incubator for nearly two years but had limited success achieving the
performance level required to pass validation and mitigate the risk of receiving an FDA
Form 483. During this time, the client’s product gained regulatory approval and
production demand began to increase rapidly. At this point, the client realized that the
competitor’s CO2 incubator could not produce the reliability and performance required
for FDA-compliant production and approached Environmental Specialties for a solution.
Solutions
Our controlled-environment chambers and incubators are recognized across the life
sciences industry for performance and reliability. The incubators Environmental Specialties delivered to the client:
- Improved temperature uniformity from ±1.0°C to ±0.4°C under fully loaded conditions.
- Doubled the throughput capacity of the cell culture process.
- Reduced validation time by eliminating performance qualification failures.
- Decreased product rejections due to out-of-tolerance temperature conditions.
- Lowered the client’s total cost of ownership by reducing incubator down time.
- Mitigated the client’s FDA audit and recall risk.
Client Background
The client is one of the largest global biotechnology companies that produces lifesaving
vaccines, therapeutics, and drugs.