Recipharm is a leading global pharmaceutical Contract Development and Manufacturing Organisation (CDMO). They provide pharmaceutical companies around the world with tailor-made development and manufacturing services, including a wide variety of drug dosage forms, inhalation products and devices.
Recipharm Queenborough Ltd is one of Recipharm’s multi-purpose facilities, located in the southeast of England, providing bulk manufacturing and packaging of solid and liquid pharmaceutical products in blister packs and bottles.
For companies like Recipharm Queenborough Ltd, who are manufacturing and packaging pharmaceutical products, it is imperative that the packaging maintains its integrity from the point of manufacture to delivery to the end-users, protecting its contents from any external contaminants.
In order to ensure this integrity, it is necessary to test the packaging, which can be done in a number of various ways. Until recently Recipharm Queenborough Ltd were testing the seal integrity of their blister packs by pulling a vacuum manually and timing the sequence with a stopwatch, which can be complicated, time-consuming and open to a lot of user subjectivity.
They made contact with LIMAB UK and have now implemented a Dynascan MediBLUE, which has not only simplified the process but has also reduced the possibility of user error making it more consistent, reliable and dependable.
Colin Franklin, Packaging Technical Specialist at Recipharm Queenborough Ltd said:
Prior to contacting LIMAB UK, we were manually testing the seal integrity of our blister packs, which we felt could be improved upon. After a conversation with Kevin Goodison, the product specialist at LIMAB UK, we decided to implement a Dynascan MediBLUE. We have found the addition of the Dynascan MediBLUE to our manufacturing process absolutely invaluable. The Dynascan MediBLUE is very easy to use, simple to operate and we have found that it saves us a great deal of time and resources. There is less risk of user error and subjectivity and on the whole we are pleased with the Dynascan MediBLUE. Throughout the purchase process, we found Kevin to be extremely knowledgeable, very helpful and we would not hesitate to recommend LIMAB UK.
The Dynascan MediBLUE automates the industry-standard methylene blue dye test. The blisters are submerged into a blue dye solution, the test chamber is then placed under a vacuum, which forces air from any holes in the packaging. After returning the test chamber to ambient pressure, the dye will penetrate the packaging and be visible in the packaging if any holes are present.
The Dynascan MediBLUE is available in two configurations, the pre-set and the programmable.
The programmable system allows the user to set the test vacuum, vacuum hold and ambient dwell times during the packaging development process to determine the optimum test conditions. The system can be locked into a run mode, preventing any unauthorised changes to the test method.
Whilst 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 and of any fault conditions.
If you would like to find out how the implementation of a Dynascan MediBLUE could improve your manufacturing processes please visit our website or contact our product specialist.
