Dalton - Pharmaceutical Contract Manufacturing Company

From April 1986 to April 2000, Dalton Chemicals, 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 production area, synthetic and analytical laboratories, technical support services as well as technical writing areas and offices.

Construction began in November 1999 and was completed in April 2000.

                   

Renovation History

Phase I Renovation – 1999-2000 Research and Analytical laboratories, GMP area, technical and administrative office construction

Phase II Renovations – Spring 2001 Sterile filling room construction
Autoclave and process equipment installation.

Phase III Renovations – Summer/Fall 2003 Oligo laboratory, peptide laboratory, microbiology laboratory construction
QA Sampling area 


The Facility

Dalton’s facility is comprised of the following technical and administrative areas:

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

Personnel Airlock
Materials/equipment Airlock
GMP Suites (2)
Sterile Filling Room
Autoclave Room
Equipment/Glass Wash Area
Product Storage Room

The environmental conditions within the GMP 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 facility is under positive pressure relative to the warehouse and the writing area corridor. Access to this facility is restricted to authorized personnel and is controlled via a 24/7 proximity access card system.

GMP Suites
These rooms were designed for the production of APIs. Each 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.

Sterile Filling Area
A sterile 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 Chemicals is capable of producing fine chemicals in multi-kilo batches using 22 L, 30L, 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. Plans are under way to locate a LC-MS a new laboratory area. Stay tuned to our website for further details!

Peptide and Biopolymer Area
The peptide synthesis group was provided with this area in 2000 when peptide synthesis became a new business area for Dalton Chemicals. This group currently has use of one bench top fume hood, a walk-in fume hood and several other pieces of equipment, including two peptide synthesizers. As this business area has continued to grow, it was recognized that a larger lab was required. Plans are underway to begin construction of a new 900 square foot peptide laboratory in Fall 2003.

Oligo Laboratory
A recent addition to the many services offered by Dalton, the Oligo Laboratory was designed to accommodate the equipment used by the staff in the production of anti-sense and large scale diagnostic oligos. There are four AKTA oligopilots which can produce milligram to gram quantities of high purity oligos.

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 2L 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 Sterile Filling Production.

Facility Amenities
►Building Automation System, 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.