New qualification and validation strategy
Quality by Design (QbD) is a process by which quality is systematically built into a product and production process during the development phase. When applied consistently, it is the most reliable and cost-effective way to bring complex products to the market. Pharmaceutical and medical technology specialist Gerresheimer has an integrated tool qualification and validation strategy in place so that it can develop products to the marketing stage quickly and cost efficiently. It also provides a process window for stable series production and options for different application scenarios and qualification levels.
Pilot production in series quality
Pharmaceutical and medical technology products have to go through lengthy licensing procedures in advance of series production and small quantities of the product have to be regularly produced as clinical samples or stability batches. Gerresheimer Medical Plastic Systems opened its own Technical Competence Center in Wackersdorf for small batch production. The TCC manufactures products in series quality and the knowledge gained can then be directly incorporated in the mass production process at the Gerresheimer facility of the customer’s choice.
Only recently a major pharmaceuticals Gerresheimer presents its Medical Plastic Systems at Compamedcorporation requested Gerresheimer to manufacture an auto-injector. It is manufactured at the Gerresheimer Küssnacht plant in Switzerland. The auto-injector is composed of fourteen plastic components and three metal parts. The plastic parts are produced by Gerresheimer, then made into two subassemblies for final assembly and filling on the customer’s premises. The pharmaceutical drug is for the treatment of medium to serious active psoriasis arthritis.