Pharma Tech Industries, a pharmaceutical contract manufacturer and packager of powder products, recently introduced a highspeed bottling line for the production of Rx, OTC, and nutritional ingestible products at its facility in Union, Mo. The bottling line is housed in a new, specially-built ISO 8 Class 100,000 controlled environment designed for non-sterile Rx pharmaceutical-grade oral products. All equipment is of modular, quick-change design to enable minimal downtime between campaigns.
Controlled Environments spoke with Tee Noland, Chairman and CEO of Pharma Tech Industries, about this cleanroom facility addition.
Who designed/built the new cleanroom? What was the cost?
Designed by Alan Alewine with architectural services provided by Bates & Associates Architects of Springfield, Mo., and mechanical engineering design completed by Design Mechanical Inc. of Chesterfield, Mo. The cost was $1.5 million.
How long did construction take? Where did production take place during the construction process?
Construction took eight months. Production took place on a slower existing line until construction was complete.
What’s the square footage of the cleanroom area? What about other areas like a gowning area/ante room? How big is the overall facility?
Facility is 55,200 square feet; gowning and airlock is 441 square feet; processing is 3,146 square feet; secondary case packaging is 1,715 square feet; 428 square feet of equipment cleaning room.
How does the new facility differ from your previous facility?
The new facility separates the filling process into rooms or cells to reduce risk of contamination and allows each cell to support the output of the high speed line.
What kind of instruments and equipment are used in the clean area?
A high speed filling line includes unscrambling, filling, checkweighing, metal detection, capping, induction sealing, bundling, and casepacking equipment. The filling occurs in an ISO 8, Class 100,000-capable controlled room designed for non-sterile Rx pharmaceutical grade oral products.
How many employees does the cleanroom area have? What kind of work do they do?[We have] 12 employees. Seven employees work the production line; they are responsible for keeping machines running according to the validated process. Two employees monitor the product coming from the production line; they are responsible for AQL checks per customer requirements. One employee leads the production line and is responsible for staffing, documentation, and reporting. One employee supplies the line and is responsible for keeping components loaded for employees to use. One employee in maintenance is responsible for any maintenance work needed during process or while room is down.
Describe the cleaning process — does your existing staff perform these duties, or do you hire it out to another company?
The cleaning process is done by the production crew (10 of the 12 employees). The cleaning process was established and validated before the production line started. Contact parts are rinsed with hot potable water, scrubbed, rinsed with hot potable water, rinsed again with USP Purified water, and sanitized with 70 percent alcohol. The processing room and equipment that cannot be removed are cleaned with hot potable water and sanitized with 70 percent alcohol.