GMP Manufacturing Facility

Raleigh Molecular runs GMP manufacturing facilities at its Raleigh, USA site. The site saw substantial upgrades and expansions in 2016, which included revamping the sterile filling suite with new HEPA systems, RABs on the fill line, a new WFI system, enhanced vial washing and depyrogenation capabilities, and improvements in material and personnel flows.

As a Pharmaceutical Contract Manufacturing Company, Raleigh Molecular’s GMP Manufacturing Facility consists of the following technical and administrative areas:

GMP Manufacturing and Aseptic Filling Area

The cGMP Manufacturing Facility spans approximately 2,500 square feet (232 square meters) and incorporates distinct rooms dedicated to the following production functions:

  • Personnel Airlock
  • Materials/equipment Airlock
  • cGMP Suites (2)
  • cGMP Aseptic Filling Room
  • Autoclave Room
  • Equipment/Glass Wash Area
  • Vial wash and depryogenation room
  • Product Storage Room

Regular monitoring occurs within the GMP Manufacturing Facility to uphold environmental conditions such as temperature, humidity, air pressure, and air quality. Access is strictly limited to authorized personnel and managed through an access card system.

GMP Suites (2 suites)

The suites were specifically designed for the production of APIs. Each GMP Manufacturing suite is equipped with stainless steel tables, an 8-foot walk-in hood, and a 6-foot benchtop fume hood. Terminal HEPA filters are strategically positioned throughout the ceiling to uphold air quality standards. The walls, ceiling, and floors are coated with a highly durable epoxy-based material to ensure a consistently high level of cleanliness. These manufacturing suites adhere to a Grade C classification.

Aseptic Filling Area

The GMP Aseptic Filling area was initially built in 2014, spanning approximately 300 square feet (28 square meters). It features a cleanable modular wall system and includes essential components such as a material air lock and a personnel airlock for gowning, ensuring compliant material and personnel flow. The fill line, operating under Restricted Access Barrier Systems (RABs), maintains a localized Grade A environment. Terminal HEPA filters are situated in the ceiling for air purification. Pressure, temperature, and humidity levels are continuously monitored via Raleigh Molecular’s Building Automation System. Additionally, a comprehensive environmental monitoring program is implemented for the GMP area.

Autoclave Room

Situated within the GMP area, this room ensures a localized Class A environment for all clean items emerging from the autoclave. The autoclave, installed in 2014, is complemented by additional process equipment such as a pure steam generator, a plant steam boiler, and an RO/DI purified water system. The input side of the autoclave is positioned in the GMP Equipment/Glass Wash Area.

Water System

In 2018, Raleigh Molecular installed and qualified a new Steris WFI system to meet the operational requirements of the GMP production areas, including the newly added vial washing and depyrogenation room. The WFI system adheres to regulatory requirements from the U.S., EU, and Canada.

QA Sampling Room
This 100 square foot (9.3 square meter) room segregates the sampling of solvents and other raw materials for GMP. This room features a fume extractor arm and stainless steel benching for work space.
Laboratory Services
To maintain efficiency and safety in the laboratories, separate rooms were developed to accommodate the following activities:
  • Hydrogenation Room (location of 2 x 2 L Parr Reactors)
  • Solvent Storage and Dispensing
  • Waste Solvent Storage
  • Gas Cylinder Storage
  • Glass Wash and Storage
  • Retained Sample Storage
Synthetic Laboratories (R&D Area)

There are two synthetic production laboratories, each spanning approximately 1,100 square feet (102 square meters). These labs are equipped with benchtop fume hoods and one or two walk-in fume hoods. Raleigh Molecular is proficient in producing fine chemicals in multi-kilo batches using glass reactors of capacities such as 22 L, 30 L, 50 L, 100 L, and 250 L.

Additional Facility Amenities
  • Building Automation System (BAS), which continuously monitors temperature, humidity and pressurization in all laboratory areas. In addition the system monitors the higher hazard areas of solvent storage and the hydrogenation room in case of solvent leak and/or fire.
  • Security system with proximity card access to critical areas. The GMP facility also has additional security cameras for observation purposes.
  • Over 6,000 square feet (557 square meters) of technical writing areas, administrative and management offices.
  • Separate shipping and receiving bays located in rear of facility ensuring smooth intake of materials and output of product.

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