Friday, May 1, 2009

GMP Manufacturing and Sterile Filling Area

GMP Manufacturing and Sterile 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)
* Sterile 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.

Sterile Filling Area
A GMP 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, 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 LC-MS 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 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 (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.

Facility Vision to 2011

GMP Facility Expansion
As a GMP synthesis manufacturer, we are now in the final stages of planning and design of our GMP facility expansion.

We will be adding the following capabilities to our existing GMP Manufacturing and sterile filling operations.

* Materials Process & Preparation area
This area will be equipped with a high capacity Fedegari autoclave, a large scale Gruenberg pass-through depyrogenation oven, a smaller scale Despatch pass-through depyrogenation oven and a high speed Cozzoli vial washing line coupled with a Bosch/Strunck depyrogenation tunnel.
* Sterile Fill Rooms
The new facility will contain four new fill rooms each equipped with different filling equipment including a Cozzoli high speed vial filling line, a Cozzoli syringe filler, a Flexicon semi automatic vial filling line and a M&O Perry powder filler.
* Formulation Rooms
We will be constructing two Formulation rooms equipped with a separate equipment wash and preparation area including Clean-in-place/Steam-in-place capabilities.
* Lyophilization
This service will be added during the third phase of construction. We are considering a smaller scale and a larger scale unit which would allow us the capability of lyophilizing for R&D and scaling up when necessary.
* Label and Clean Packaging Room
This room will allow us to properly label and package all of our manufactured goods according to our customers needs.

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