The Norwich Pharma Services manufacturing facility in Norwich, New York is as varied in its capabilities as it is its equipment investment strategy. This dedication to growth through equipment and technology investment has led to it being recognized as one of Pharmaceutical Processing’s Facility Excellence Award winners for 2014.
The facility, which has been in operation since 1976, provides 375,000 square feet of operational space in producing approximately four billion solid oral dose units per year. With GMP-compliant equipment and production capabilities throughout, the facility can handle clinical, commercial and contract manufacturing within the same walls. This dynamic helps cut product development and regulatory approval timeframes, as well as the associated costs.
From buying API to product distribution, the facility offers Phase I - III product development in solid oral dose tablets and capsules, as well as liquid doses. Manufacturing operations include blending, encapsulation and coating, as well as fluid bed, blister packing and liquid fill packaging.
Overall, growth in solid dose products has been stagnant, with the primary exception being high-potency oncology products. In responding to this trend, Norwich has invested in equipment that is sized specifically for handling such products and the smaller batches these compounds represent.
The facility can handle all phases of product development, starting with the pilot and scale-up stages, through production and including product packaging. And as the pharmaceutical industry continues to rely more and more on outsourcing, Norwich’s ability to handle early lifecycle projects has led to a number of long-term relationships.
Examples of the investments that the Norwich facility has made in order to grow its clinical, commercial and contract customer base includes:
- 8,000 square feet of DEA-approved solvent and potent compound capable space.
- Two laboratories dedicated to providing solid dose development and manufacturing technologies in both R&D and GMP environments.
- The pilot scale facility’s equipment and technology mirror commercial scale capabilities, allowing for direct transfer from analytical to quality control.
- In the last 12 months, Norwich has nearly tripled its pilot-unit capacity to a total of 19 rooms. Each has the ability to handle Occupational Exposure Limits (OELs) for drug potencies ranging from category one to three.
- All manufacturing suites are equipped with HEPA filters to prevent cross-contamination between rooms. For maximum environmental control, a Honeywell® system tracks pressure differentials, temperature, and humidity levels throughout the manufacturing and warehouse facilities.
- Some of the newer technologies being tested in the pilot scale facility include laser drilling for osmotic delivery, tablet in capsule and bi-layer compression.
- Fluid granulation capacity has been expanded, along with low-humidity manufacturing and packaging in order to match the pilot unit’s capabilities. Ultimately, the goal is to take all the equipment and technology from the pilot scale operation and emulate it on the commercial manufacturing side of the business in providing customers a seamless scale-up. Low humidity capabilities have been expanded to handle products down to a 30 percent humidity environment.
- On the commercial manufacturing side, Norwich has expanded their blending technology options by adding bin blending to match their pilot-unit capabilities. Many newer products are being processed using bin-blenders because they offer the potential for better uniformity and the ability to overcome obstacles in product robustness.
- Packaging capabilities have been expanded, with speeds improving 25-50 percent, depending on bottle size.