Business Expansion

The situation:

Generex Biotechnology wanted to develop a clinical manufacturing plant to manufacture a novel aspirator spray delivery system for a medical device product. Initially, they wanted a pharmaceutical plant layout to produce the product in 3 small industrial units. The client did not have the expertise to design or furnish the warehousing, office, laboratory or maintenance, and did not have pharmaceutical manufacturing engineering expertise. All the work had to meet both Canadian and US pharmaceutical standards

Our Response:

Crawford developed a pharmaceutical layout that fit the entire plant into an extremely small space, eliminating the need to rent outside facilities. Using our pharmaceutical engineering expertise, we developed the full process from receiving, storage, compounding, filling, packaging, warehouse and shipping. We provided the material handling expertise for the product flow, warehouse racking, trays, carts, etc., resulting in efficient flow of material. We brought in a specialist to determine the labour required for the process, and to write job descriptions. All maintenance operations were included.

The Result:

The client trained and staffed the plant during the validation period. The facility opened and was immediately able to manufacture products in accordance with the protocols for the Canadian clinical market. The client was able to concentrate on their research, while we took care of the details of the plant start-up. By providing a one-stop-shop, the client’s headaches were reduced, while their business grew.

Renovation of a vacant warehouse into a clinical manufacturing plant
producing aerosols, meeting US FDA standards in Toronto, Ontario.