Sharp UK adds a new capability to its service portfolio in response to client demand
Sharp UK first began to support medical device trials back in 2013, having won a contract to package and distribute phase III clinical trials for a medical device company. The trials were successful and having been granted approval by the FDA and EMEA, the product subsequently moved into the commercialization phase.
Proven to be an excellent contract partner throughout the trial and with the necessary expertise and experience, the client decided to award the contract for the commercial phase of the product to Sharp. The services required to support the commercialization phase included labeling and kit assembly in two parts: a drug substance and a medical device delivery kit.
- Lyophilised vials needed to be packed and labeled into product cartons.
- Delivery kits, which included a spray device, flexible nozzle and filter, were to be packed into one carton box.
Adapting to ensure delivery
Sharp’s UK team had to take a number of steps to ensure it was able to support this new medical device product.
Approval from the relevant regulatory authority to be able to label the medical device required ISO9001 and ISO13485 accreditation which was attained. Sharp’s logistics team reconfigured elements of the ERP system (SAP) to optimize management of the project for the client. At the facility itself, the existing packaging and warehouse capacity was expanded, and then validated, to meet the demands of the work.
This was a milestone in the ongoing development of Sharp UK, marking its entry into commercial packaging of medical devices.
The additional challenge the team faced was to create a segregated commercial packaging facility, documented production and Quality Management System and deliver a dedicated team to work alongside the current clinical trial business at the facility. This was realized by extensive planning and careful execution to meet the customer’s timelines and quality requirements.
As well as this being Sharp UK’s first venture into commercial packaging it is also the first time the customer had produced a commercial pack so the knowledge and expertise of the staff at Sharp proved to be essential to the success of the project.
Since that first customer back in 2013, Sharp has gained vast experience with medical device packaging and today we work with numerous medical device companies operating ISO certification.