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Pharmaceutical Contract Manufacturing Company
 

 
 
 

GMP Manufacturing Facility

As a Pharmaceutical Contract Manufacturing Company, Dalton’s GMP Manufacturing Facility is comprised of the following technical and administrative areas:
 

GMP Manufacturing and Aseptic Filling Area
The GMP Manufacturing Facility is approximately 2,500 square feet and includes separate rooms for the following production functions:

  • Personnel Airlock
  • Materials/equipment Airlock
  • GMP Suites (2)
  • Aseptic Filling Room
  • Autoclave Room
  • Equipment/Glass Wash Area
  • Product Storage Room
The environmental conditions within the GMP Manufacturing Facility, including temperature, humidity, air pressure, and air quality are monitored at regular intervals and aseptic conditions are maintained through routine cleaning. The entire GMP Manufacturing Facility is under positive pressure relative to the warehouse and the writing area corridor. Access to the GMP Manufacturing Facility is restricted to authorized personnel and is controlled by an access card system.
 

GMP Suites
These 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 constructed during Phase II Renovations in Spring 2001. This area is approximately 300 square feet in size and is constructed with an aluminum frame and polypropylene walls and ceilings. The area contains a material air lock, a personnel airlock for gowning and a localized Grade A area for the semi-automated filling machine. There are terminal HEPA filters located in the ceiling and pressure, temperature and humidity are all monitored continuously through Dalton’s Building Automation System. A full environmental monitoring program is in place for this area and for all additional rooms in the GMP area.
 

Autoclave Room
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 during Phase II Renovation in the Spring of 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.
 

Synthetic Laboratories
There are two synthetic production laboratories approximately 1,100 square feet each. Each laboratory has eight bench top fume hoods and one walk-in fume hood. Dalton Pharma Services is capable of producing fine chemicals in multi-kilo batches using 22 L, 30 L, 50 L and 100 L glass reactors.
 

Analytical Laboratory
Our Analytical Services area was architecturally designed to house a vast array of analytical equipment. Each HPLC, CE, GC, titrators and other pieces of equipment are located for maximum efficiency of space and data communication. The analytical team has the use of bench top fume hoods as required. We have added liquid chromatography mass spectrometry capabilities with our latest addition, an LC-MS laboratory area.
 

Microbiology Laboratory
This 350 square foot 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 GMP area.
 

QA Sampling Room
This 100 square foot room has been designed in order to completely segregate the sampling of solvents and other raw materials for GMP. This room features a fume extractor arm and some stainless steel benching for work space. Access to this room is restricted to authorized personnel only.
 

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
These rooms operate under restricted access and have segregated areas for those items used in GMP and Aseptic Filling Production.
 

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.
  • Validated USP Purified Water System and Pure Steam Generator
  • Newly refurbished boardroom, lunch room, and employee locker rooms.
  • Over 6,000 square feet of technical writing areas, administrative and management offices.
  • Separate shipping and receiving area located in 18,000 square feet of warehouse and future expansion space.

Renovation History

From April 1986 to April 2000, Dalton Pharma Services, through Innovation York, had the use of 6,000 square feet of synthetic chemistry laboratory and office space at York University. Experiencing tremendous growth in the late 1990s, Dalton began the search for an off-campus location in close proximity to York University.
 

In August 1999, 349 Wildcat Road was purchased; this 42,000 square foot building had approximately 7,000 square feet of existing office space and 35,000 square feet of warehouse space. The building retrofit was designed and engineered by Levine Lauzon Architects and Crossey Engineering Ltd. The building was renovated to accommodate a GMP Pharmaceutical Contract Manufacturing production area, synthetic laboratory, analytical laboratories, technical support services as well as technical writing areas and offices.
 

  Phase 1: 1999-2000 Research Labs, Analytical labs, cGMP manufacturing area, technical and administrative office construction office construction.
  Phase 2:
Spring 2001: Aseptic Filling room construction, Autoclave and process equipment installation.
  Phase 3:
Fall/Winter 2003: Bipolymer lab, microbiology lab construction, QA sampling area.
  Phase 4: Summer/Fall 2004: Level 6 Controlled Substances room, LC-MS laboratory.
  Phase 5: Summer/Fall 2005: GMP Oligonucleotide Manufacturing Facility.
  Phase 6:
Fall/Winter 2005 - 2006: GMP warehouse, Controlled Access Stockroom, Controlled Access Stability Testing and Environmental Testing chamber area, Column Preparation room.
  Phase 7:

Fall/Winter 2007 – 2008: Building Management System including Building Monitoring System, building video security system, expansion of Analytical Testing Laboratory, ICH compliant sample retention area, purification lab, installation of 8 additional fumehoods, third validated LCMS, second Dionex 

  Phase 8: 2009/2010 - Construction of Solid Dose Compounding and Capsule Filling Facility
  Phase 9: 2011/2012 - Expansion of Maintenance Shop, addition of New GMP Change area, New Shipping area and refinishing of floors