Established in 1975, in the pharmacy department of Torbay Hospital, Torbay Pharmaceuticals now operates from a 76,000 square feet, state-of-the-art UK-based manufacturing facility.
Part of the Torbay and South Devon Healthcare NHS Foundation Trust, Torbay Pharmaceuticals is the largest NHS-owned contract manufacturer of pharmaceuticals for Analgesia, Anaesthesia, Cardiovascular System, Gastrointestinal Systems, Nutrition and Blood and Ophthalmology.
They hold eight UK Marketing Authorisations for products that are available for supply into global export markets and also supply several unlicensed pharmaceutical specials that can be supplied within the EEA.
Torbay Pharmaceuticals first made contact with Control Metrix in February 2022. Their existing seal integrity testing method was proving unsatisfactory and they were looking for an alternative method.
Joe Uglow, Validation Manager at Torbay Pharmaceuticals said:
We were looking to replace our existing seal integrity testing method and after putting together a User Requirement Specification (URS), I searched online for ‘seal integrity testing’ and Control Metrix came up. I gave them a call and I was put in touch with the product specialist, Kevin Goodison. We had a meeting to discuss the URS and we decided that a custom-made, bespoke version of the Dynascan MediBLUE Pre-Set would meet our requirements and I placed an order. Throughout the process I was very impressed with Kevin’s evident product knowledge and expertise. He was able to develop a custom-made solution for a complex requirement and was also able to provide the relevant training. I found the team to be very professional and I will most definitely be using them again in the future.
The Dynascan MediBLUE Pre-Set
The Dynascan MediBLUE Pre-Set automates the industry-standard Methylene Blue Dye test, where packaging is submerged into a blue dye solution. The test chamber is then placed under a vacuum that forces air from any openings within the pack. After returning to an ambient pressure, the dye will penetrate and be evident within the pack should any holes be present.
Blue dye testing has proven to be a popular package leak detection option within industries such as pharmaceutical, medical devices and consumer products. This is due to its simple, valid and reliable results, in addition to low capital costs. The MediBLUE Pre-Set does not require any software validation, the system is supplied pre-set with parameters, as specified by the users’ S.O.P. Both audible and visual alarms are integrated into the instrument, to alert the user at the end of each test cycle.
If you would like to find out how the implementation of a Dynascan MediBLUE could improve your manufacturing processes, please contact our product specialist.
