An FDA audit is a testing time – in every sense of the word – for many businesses. And even the largest businesses can find themselves falling short of requirements for FDA compliance.
In the case of one global pharmaceutical and healthcare company, it was the manway door seals on their storage vessels at one of their UK facilities which failed to meet with the FDA auditor’s approval. To achieve the necessary compliance before production could start, all the seals on all the vessels – each one with a capacity of thousands of litres – had to be changed.
Faced with the potentially tricky task of finding a suitable sealing material, and given the scale of the replacement operation and the speed at which it needed to be carried out, the company called in ERIKS Seals and Polymer to lend their expertise and assistance.
Making the difference
Following on from the FDA’s inspection of the vessels and their hatches, ERIKS carried out their own survey, and discovered the job was even more complex than it first seemed.
The seals were made from a multitude of materials. Some included adhesive backing. All this was questionable in terms of FDA compliance. And to complicate matters even further, almost every single manway hatch had different hardware, with little consistency of size or hatch closure methods.
The only realistic solution – as recommended by ERIKS – was to manufacture a unique seal for each closure. And the way to do this most economically was to take advantage of the ERIKS Seals and Polymer on-site gasket cutting capability, at the ERIKS Gaskets Technology Centre in Barnsley.
Using the Centre’s capabilities, sealing material could be cut from sheet to suit each unique closure. The next question was: sheets of what?
Making the grade
Finding a single material which would seal effectively and meet the FDA’s requirements would rationalise purchasing, manufacturing and – most importantly – eliminate the need for multiple compliance submissions to the FDA audit team.
ERIKS’ recommendation was Leader Clipperlon 2115 USP.
Leader Gasket Technologies is an ERIKS flagship brand for innovative metallic, semi-metallic and soft gaskets. At the time of the pharmaceutical company’s FDA audit, the Clipperlon material grade 2115 had just gained USP Class VI (United States Pharmacopeia-6) compliance. This meant the material not only more than met the requirements of the company’s FDA audit, but its high level of compliance would also future-proof the seals.
In addition, the company’s vessels store a large variety of chemicals. Using Clipperlon 2115 USP – with its broad range of chemical resistance – would enable rationalisation of materials, to cut costs and simplify procurement.
Designed to succeed
One particular issue the FDA auditors had with the seals was their potential to fall into the vessel during opening or closing of the hatch, if they were not in the right position.
Obviously this would contaminate the vessel’s contents and thousands of litres would have to be disposed of.
ERIKS Seals and Polymer recommended a seal design which incorporated either extending tabs on the outer diameter of the gasket, or slots for the hinge and swing bolts used to secure the lid. These would make it virtually impossible for the seal to pass through the hatch opening.
With the designs approved, ERIKS took the precaution of cutting a cardboard template of each one and testing it on site, before going to the next stage of cutting it from the Leader Clipperlon 2115 USP material. This ensured the design was practical, and guaranteed a correct fit first time for the finished seal.
With all the new seals designed, cut and fitted, the pharmaceutical company’s facility was able to continue with the start-up of their manufacturing process, and moved an important step closer to passing the all-important FDA audit.