Controlled Environments spoke to Tee Noland, Chairman and CEO of Pharma Tech Industries, a contract manufacturer to some of the world’s most trusted health and wellness brands. With fully-integrated facilities in Georgia and Missouri, the company has more than 460,000 sq. ft. of combined cGMP development, manufacturing, and packaging space. This includes nine ISO-design cleanrooms for manufacturing and packaging of Rx and NDA products, full analytical and microbial laboratories for on-site testing, and a dedicated machine shop for custom component design and refurbishment.
Controlled Environments (CE): Can you give a brief history of the Pharma Tech Industries company and facility?
Tee Noland (TN): Pharma Tech has been around since 1972. In 1990 my father, Ted Noland, purchased the business based in Union, Mo. and focused production more specifically on solids and powders. After acquiring a Johnson & Johnson Consumer facility in 2005 in Royston, Ga., Pharma Tech now encompasses more than 400,000 square feet of cGMP production space. Today we’re considered a leading end-to-end supply chain solutions company that provides turnkey, formula-to-finished product manufacturing solutions for customers in pharmaceutical, nutraceutical, and greater healthcare sectors.
CE: Talk about what went into designing your cleanroom facility – the planning process, construction, etc.
TN: With our first prescription (Rx) product launching in 2010 in our Georgia facility, we had to learn what type of production space was necessary. Through the combined efforts of our engineering staff coupled, outside consultants, and input from our customers, Pharma Tech was able to design a cleanroom capable of meeting not only immediate needs but those in the foreseeable future.
We essentially used ISO 8 guidance to design the room with cleanable surfaces, controlled entry access, and positive, dedicated HVAC systems. We have since built six additional rooms on similar design for both Rx and relevant OTC products, including those necessitating New Drug Application procedures.
CE: What is your gowning area like?
TN: Pharma Tech has two distinct versions of gowning areas, each with their own protocol. Some of our cleanrooms have entirely separate rooms for gowning. In other instances we perform the gowning in an airlock room that separated the warehouse space from the production floor.
CE: What kind of equipment is used in the cleanrooms?
TN: We have several Bartelt-style sachet fillers, various blenders, and a high speed bottling line in our rooms. We also have low-dose capsule filling.
Among our most recent addition is a 10-lane stick packaging line, which served as an expansion of our overall packaging capabilities. As with a variety of other packaging formats, we can now provide a full line of validation and engineering services to fully meet a customer’s turnkey stick packaging manufacturing needs.
CE: Who cleans and maintains your cleanroom facilities … in-house staff or an outside company?
TN: In-house staff.
CE: Can you talk about the cleaning procedure?
TN: Pharma Tech Industries performs minor cleanings, including machine and floor washing, at least once per week. Major cleaning procedures such as thorough washing of walls and ceiling is performed with between products or once per quarter, whichever comes first.
CE: How often is the facility’s cleanroom inspected? What kind of standards and regulations do you follow?
TN: The rooms are inspected on a regular basis by clients and regulatory agencies. The rooms are designed and qualified to ISO 14644 Class 8 in the “as built” state.
CE: What do you predict for the future of pharmaceutical cleanrooms? Are there any important projects or research on your horizon?
TN: As the FDA continues to raise the bar for consumer product quality – nutritional products are a good example here – I believe there will be more and more need for cleanroom production space. While there is considerable capital expense associated with these rooms, in the end the consumer is benefiting from a more controlled, higher quality environment for their critical products. We are looking forward to launching a novel Rx powder inhalation product later this year that we believe will offer unique benefits to consumers for a variety of afflictions.
CE: Anything else you’d like to add?
TN: In general, we’re seeing indications of the overall pharmaceutical contract manufacturing industry continuing to expand in the near future, particularly as the sector experiences ongoing consolidation, mergers and acquisitions. One of the major factors for this is the relatively slow growth of branded pharmaceutical products due to increased regulatory requirements and generic competition.
Another reason for the uptick lies in what I call “customer customization.” Our business development team is noticing more small- to medium-size pharmaceutical manufacturers entering brand ownership, which is creating more niche-oriented prospective business opportunities. Brand owners also are becoming increasingly specialized in the functions on which they primarily focus. For example, many are looking to specialize in the sales and marketing ends of their operations, leaving an expanded percentage of actual product production in the hands of contract manufacturers.
These trends are among a variety of factors considered during our recent rebranding process, one which intends to make a lasting impression on these emerging, increasingly targeted potential customers.
Edward T. Noland Jr. (Tee) serves as chairman and chief executive officer for Pharma Tech Industries. He is responsible for all operations, sales, and developing and executing Pharma Tech’s strategic plan. www.pharma-tech.com
This article appeared in the April 2015 issue of Controlled Environments.