How Gore is improving operator safety in pharma
EPM sits down with Scott Ross, global product specialist for the GORE LYOGUARD Freeze-Drying Trays, to learn about lyophilsation in API manufacturing and the benefits of single-use products.
Whilst Gore may be best known for its GORE-TEX brand of outerwear fabric, the company has a rich portfolio of products that span multiple industries; from ELIXIR branded guitar strings to implantable medical devices – Gore even helped make the roof at Wimbledon stadium so matches can be held in the rain.
Nearly 20 years ago, Gore developed a single-use tray for pharmaceutical manufacturers who need to lyophilise an active pharmaceutical ingredient (API) in bulk. The GORE LYOGUARD Freeze-Drying Tray is a single-use disposable product with an integrated top barrier of ePTFE membrane that enables high vapour transmission or mass transfer during lyophilisation in an enclosed container.
Ross tells me how the company designed the product to address a range of problems that manufacturers faced when lyophilising potentially unstable APIs like polypeptides and oligonucleotides, in bulk. Of particular concern to producers are risk of operator exposure to drug product and the cost of cleaning and validating stainless steel trays after processing.
When describing the bulk lyophilisation, Ross explains how operators can be exposed to the API throughout many stages of manufacturing.
“There are opportunities along the way for the operator to be exposed to API. That can present challenges depending on whether it’s a highly potent API or what the occupational exposure band of that material is,” Ross says.
When it developed the tray, Gore’s goal was to create a product to help customers reduce exposure to API by keeping drug product contained while still enabling lyophilisation. And it seems to have been accomplished – at least according to customer reports. When discussing the value of the product, Ross explains how the number one response to the question of why our customers use the tray, is around operator safety. One customer went so far as to describe LYOGUARD tray as an additional level of personal protective equipment (PPE).
The Gore product keeps operator exposure to API to a minimum in several ways. Before lyophilisation, liquid API is filled into trays. These trays are transported to the lyophilisation chamber and loaded, presenting the potential for spills and product loss, especially when using open stainless steel trays. Each spill is potentially dangerous and could be costly to the manufacturer.
Once in the freeze-dryer, API tends to aerosolise and fly-out or be ejected from an open tray, and possibly contaminating surfaces inside the equipment. After processing, both the freeze-dryer and the tray must be thoroughly cleaned and re-validated before they can be used again. These cleaning procedures expose workers to drug product again and can add significant time and additional costs.
In particular, the process of washing a stainless-steel tray which has held an API isn’t a simple one. It requires a chemical cleaning process and after washing, assays must be used to ensure the cleaning was effective. By contrast, the GORE LYOGUARD Tray is a single-use disposable solution so no tray cleaning is required.
Of course, developing a single-use disposable product raises the question of whether it’s sustainable or not. Ross believes that the trend towards single-use in pharma answers the question of sustainability and refers to the complex requirements customers have on a case-by-base basis.
“The entire pharma industry has been moving en masse to disposable single-use manufacturing,” Ross explains. “This has been going on now for nearly 25 years in the industry and it continues.”
Certainly, understanding which model is going to work, reusable or single-use technologies, has to be determined by the customer based on their process requirements, cost concerns, analysis of the risk to operators and sustainability goals. Ross continues, “At one point, people predicted that the industry would move entirely to single-use, but people have backed off that prediction and have envisioned something of a hybrid model where you have some combination of disposable and stainless steel in the facility.”