GMP Suites (2 suites)
The suites rooms were designed for the production of APIs. Each GMP Manufacturing suite is fitted with stainless steel tables, an 8-foot walk-in hood and a 6-foot bench top fume hood. Terminal HEPA filters are located throughout the ceiling to maintain air quality. The walls, ceiling, and floors are finished with a highly durable epoxy based coating to maintain a high level of cleanliness. The manufacturing suites have a Grade C classification.
Aseptic Filling Area
A GMP Aseptic Filling area was originally constructed during in 2001. This area is approximately 300 square feet (28 square meters) in size and is constructed with cleanable modular wall system. The area contains a material air lock, a personnel airlock for gowning for compliant material and personnel flow. The fill line, which is under Restricted Access Barrier System (RABs), is under a localized Grade A environment. There are terminal HEPA filters located in the ceiling. Pressure, temperature and humidity are all monitored continuously through Dalton’s Building Automation System. A full environmental monitoring program is in place for the GMP area.
Located in the GMP area, this room provides a localized Class A environment for all clean items being removed from the autoclave. The autoclave was installed in 2001 along with several pieces of process equipment including a pure steam generator, plant steam boiler and a RO/DI purified water system. The input side of the autoclave is located in the GMP Equipment/Glass Wash Area.
Dalton installed and qualified a new Steris WFI system in 2014 to support the operational needs of the GMP production areas including the new vial washing and depyrogenation room. The WFI system is compliant with U.S., EU and Canadian requirements.
cGMP Encapsulation Suite
Dalton operates a commercial manufacturing suite for the production of oral powder filled capsules. The capabilities include a fluid bed dryer, blending and encapsulation capabilities.
Our Analytical Services area was architecturally designed to house a wide array of analytical equipment. The analytical lab supports the cGMP manufacturing services with analytical method development services, method validations, raw material release testing, in-process testing, finished product release testing as well as stability testing. Dalton utilizes current industry standard equipment including HPLC, GC, LC-MS, SEC-MALS, KF and others to support our customer requirements.
This 350 square foot (32.5 square meter) laboratory accommodates the necessary staff and equipment to support Dalton’s rigorous environmental monitoring program for the GMP area. The biological safety cabinets and incubators are used for on-site bioburden testing, microbial identification and environmental monitoring of the cGMP area.
QA Sampling Room
This 100 square foot (9.3 square meter) room segregates the sampling of solvents and other raw materials for cGMP. This room features a fume extractor arm and stainless steel benching for work space.
To maintain efficiency and safety in the laboratories, separate rooms were developed to accommodate the following activities: