Custom Processing Services has a strong track record of contract manufacturing in the pharmaceuticals marketplace. And on November 11, 2011 that legacy was strengthened with the opening of a 42,000 square foot facility dedicated to GMP processing, with two unique GMP processing stations. This commitment to new and innovative manufacturing technology and processes has led to it being recognized as one of Pharmaceutical Processing’s Facility Excellence Award winners for 2014.
Prior to this expansion, two similar rooms had been in operation for about 10 years at another of the company’s facilities. However, CPS soon realized that the increased number of requests for cGMP work had them at capacity. Additionally, they needed to expand their capabilities in order to perform smaller scale trial work. This most recent expansion covered both needs by providing:
- A two-level clean room that houses a variety of mobile mills and blenders for new trial work.
- A production-sized clean room that can be fitted with larger equipment in handling greater product quantities. CPS recently added cGMP blending capabilities to this area with 2.5 CFT, 100 CFT and 300 CFT blenders that will allow CPS to meeting a greater range of batch size requests. Additional features of these clean rooms include sanitary mills, slant cone mills, tumblers and packaging stations, all of which can be configured to a client's specific needs.
- This expansion provides application coverage for a number of segments requiring cGMP-compliant production, including personal care items, food grade products, pharmaceutical excipients, active pharmaceutical ingredients and even controlled substances such as narcotics.
- The entire facility was designed to handle up to nine more clean rooms in the future.
Additionally, recent investments in various sizes of spiral style mills will allow for expanded pharmaceutical level micronizing. This means CPS can offer batch sizes as small as 10-50 grams, and as large as several metric tons. Other production and quality assurance-oriented investments include:
- A Biokill Heat Screw unit that breaks down microbiological agents to ensure products are safe for pharmaceutical use. This gives CPS an opportunity to take materials that may be considered technical grade and clean them to the point that they are acceptable as GMP ingredients.
- A stainless steel air classifier that provides a second step after micronizing to fine tune any desired particle range, if required. This system can remove any coarse materials so the product being packaged will meet more exacting specifications.
These investments not only allow for handling trial and production runs of various sizes and quantities, but the new facility has also expanded testing and R&D functions that include cleaning and process validation. CPS feels that this range of production capabilities and end-product services allows them to cater to a customer’s specific needs in building a more personal relationship.
Along with investments in new production capabilities, CPS has looked to improve the quality of their operational processes. With this in mind the company recently unveiled a new safety system that is being applied to pharmaceutical grade products as part of the GMPs that are used on a daily basis. This includes a revised HACCP plan to ensure no foreign contaminants reach end-products, and all facilities now fall under a current ISO 9001 Quality Management System. CPS feels that this shows that they’re not only meeting, but exceeding customer requirements.
So as CPS looks to the future, they see opportunity in the changes that lye ahead. The constantly evolving needs of the pharmaceutical industry, in terms of new formulas, processes and regulations, means this contract manufacturer will need to continue to evolve and invest in order to keep pace. Their new facility and recent production equipment investments help reinforce that commitment.