Lyne Laboratories’ management team sees 2013 as being a challenging and rewarding year in their company’s history. As patents expire, Lyne is looking forward to becoming a “nichebuster” in the industry. With its primary focus on generic drug development, Lyne is committing substantial financial resources to newer facilities, which include R&D laboratories for its generic drug program. Management’s commitment to building new facilities will allow it to reduce timelines to successfully expand technologies and methods for the purpose of developing and marketing niche generic drugs. Plans have been completed for a new building, which will be opened in late 2013. At the same time, Lyne is increasing production capacity in its present facilities to meet the demand for new generics.
Lyne’s present 115,000 square-foot facility was specifically designed and constructed to support and sustain robust, modern quality systems that are consistent with cGMP regulations. Located on a five-acre campus in Brockton, Massachusetts, it is a modern, state-of-the-art facility. The manufacturing area contains nine packaging and six compounding rooms. The packaging rooms are designed to house individual operations and are equipped with HEPA filters to prevent cross contamination between rooms. The water system meets current USP specifications for Purified Water. Water is produced via various processes including reverse osmosis, deionization and filtration. The water is stored in a 2000 gallon holding tank and is continuously pumped through a recirculation loop, and filtered at all points of use.
Lyne’s other important facilities include an explosion proof building, which is detached from the main building. It houses a flammable tank farm in a state-of-the-art modular building that is designed specifically for the manufacturing of high-alcohol content or solvent-based drug products. It also includes a separate storage building for flammable materials. The tanks in the tank farm range in size from 300L up to 8000L.
The following is a brief list of equipment at the facility:
- Various tanks from 100 L up to 10,000 L, both jacketed and non-jacketed
- Ribbon blenders
- Double cone and twin shell blenders
- Pfaudler rotary liquid filling
- National Instrument Monoblock liquid filling
- Norden Tube filling and cartoning
- Healthstar unit-dose liquid filler
- Lakso slat counters for capsules
- Mateer and Spee-Dee powder fillers