Pharmaceutical manufacturing is a very precise science with little to no room for variation in the synthesis process. Companies spend millions of dollars on research and development to perfect drug formulas before they can go to market. With all of the time and money spent on developing these drugs, companies often overlook the importance of proper sealing for medical containers. Each year, pharmaceutical companies lose hundreds of thousands of dollars of finished goods due to contamination during canister sterilization and transport. Parker’s custom Gask-O-Seal technology combines 316 stainless steel with Parker’s E3609-70 ethylene propylene to provide superior sealing throughout pharmaceutical packaging and transportation.
Pharmaceutical containers are highly regulated by the Food and Drug Administration (FDA) and must be sterilized before and after the drugs have been placed in the containers. Parker Composite Sealing Systems Division has developed three Gask-O-Seals to alleviate the common issues facing previous sealing methods. Typically, PTFE rings are used to seal each canister. However, when these canisters go through the sterilization process, the high temperature (124°C) and steam cleaning causes these rings to relax. With the loss of torque each canister would fail the helium leak test causing downtime in production, as well as loss of finished goods during transit. Parker's seals were designed to solve these leak problems by using an elastomeric seal with a metal retainer providing a more robust and complete sealing solution. With the elastomer acting as the sealing element and the metal retainer acting as a compression limiter between the canister and the lid, they no longer experienced torque loss. In the elastomer selection process, we put multiple compounds through a moisture vapor transference test in order to make the best selection. This test data proved that our E3609-70 ethylene propylene was best suited for keeping moisture out of the canisters due to its temperature capabilities and superior vapor resistance.
In order to prevent cross contamination between our seal and the pharmaceuticals in each canister, our seals had to be designed without the use of chemical bond to keep the elastomer attached to the metal retainer. In order to do this, our engineers designed this seal utilizing mechanical bonding techniques to prevent our chemical bonding agents from contaminating the chemical formulations.
Potential for this product line
Pharmaceutical canisters are not the only viable market for a product like these Gask-O-Seals. I-Line gaskets are used in the processing pipeline systems for the food, dairy, beverage and bio tech industries, as well as the pharmaceutical industry, all of which require similar standards in their sealing options. Our product has already proven its exceptional performance during sterilization while eliminating the possibility for cross chemical contamination.
Parker Composite Sealing Systems Division offers a multitude of sealing options so let us help you with your next project. For more information on our unique sealing solutions, contact the experts at the Composite Sealing Systems Division.