Changing from Disposable to Reusable

Jan Eudy
November 2004

Of all of the components that comprise cleanroom operations and processes, humans are the easiest to control, yet contribute the most contamination.
Over the years the contamination control industry has evolved unique, innovative fabrics and apparel to encapsulate humans working in the cleanrooms thereby protecting the product and the processes from possible deleterious contamination.
Historically, cleanroom garments constructed of nonwoven materials were used in cleanroom environments because of the small pore size and availability of product from suppliers of other disposable cleanroom products.
Over the past ten years, a new generation of fabrics constructed of 100% polyester and durable carbon threads, and cleanroom compatible snaps, zippers, and binding has been developed. These garment systems are lightweight, non-linting, economical and have small pore sizes to control both non-viable and viable particle contamination. There now are fabrics specifically designed to meet the requirements of the pharmaceutical, biopharmaceutical, and medical device industries.
The validation of reusable garments versus disposable garments begins with the Master Plan. The Master Plan is the overview of the life cycle of the validation process. A Master Plan outline is created that defines the steps and benchmarks of developing the validation protocol, the installation qualification, operation qualification, performance qualification, and change control.
In all of these phases, Standard Operating Procedures (SOPs) are prepared and serve as the blueprint to perform each of the qualifications. A change control process is used, if any part of these results fails to meet the required specifications, to make a change to either the specification or the system.
Once the validation protocol is developed, the SOPs written, training and responsibility assigned, the validation process is initiated.
The installation qualification (IQ) documents that the reusable garment compares at minimum equally in fabric, construction, and barrier specifications, if not better than the currently used disposable garments. All of this supporting data and documented evidence is usually provided by the supplier of the reusable and disposable garments.
The operation qualification (OQ) documents that the reusable garment system compares equally during normal processing operations, if not better than the currently used disposable garments. Typical environmental monitoring test results of both viable and non-viable particles of the cleanroom air, surfaces, and personnel monitoring should provide the required documented evidence to compare the reusable garment system versus the disposable garment system.
The performance qualification documents that the reusable garment system compares equally over an extended period of time, if not better than the currently used disposable garments. The same environmental monitoring test results of both viable and non-viable particles of the cleanroom air, surfaces, and personnel monitoring should provide the required documented evidence to prove the reusable garments are as robust and reproducible as the disposable garments.
During the validation process, changes may be required. Change control is the process to provide documented evidence of any change that has been performed, for any reason. Once it is determined that change is required, the change is documented and implemented. After implementation of the change, the changed process must be revalidated.
Once all the documentation is accumulated from the installation qualification, operation qualification, and performance qualification, a summary report is prepared. This completes the validation process and completes the execution of the Master Plan. The summary consists of a summation of the life cycle that has been outlined in the validation protocol, documentation of the testing, and verification of test data. Once data is compiled and verified, statistical analysis is performed on the data and included in the summary report.
The reusable garment systems are more economical and durable than the disposable garment systems. How many times have you put your foot through the leg of a disposable system and torn the disposable material?
Additionally, the reusable systems are more environmentally friendly. With the introduction of the ISO Environmental Standard 14000, the use and cost of disposal of all disposable products is scrutinized by upper management and the government.
For more information, please contact Jan at eudyj@cintas.com. If you have a question for Jan on cleanroom apparel, send it to pnesdore@a2c2.com.

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