The demand from the pharmaceutical industry for single use-process components and -assemblies is increasing sharply. This trend has been visible for years, but has been strengthened significantly because of the activities surrounding the production of COVID-19 vaccines. With aseptic single-use process systems, pharmaceuticals are capable of quickly introducing a vaccine for the lowest possible costs. As a result of the increased demand, the delivery times from the manufacturers of single-use-components and -assemblies has increased. Sometimes even up to more than six months. Buyers for pharmaceutical companies are now in front of the challenge to prevent the delay of the vaccine production due to lack of materials as much as possible.
Supplies and agreements
As distributor of single use-technology, we at hitma have increased our supplies because of the corona epidemic. To ensure we primarily buy the correct products, we have intensive contact with our customers and determine with them what they specifically need for this and next year.
Personally I believe that most of the delivery time problems could have been prevented if manufacturers of single-use materials made agreements about guidelines and standardization.
At the end of 2016 i already argued for a database with information about pressure tests and about leachables and extractables in relation to different materials from which single-use products are created, but this has still not happened. I believe the solution lies with the regulations. So with the FDA.
For the pharmaceutical industry, simplification would be a step in the right direction. The interpretation of risk analyses is something pharmaceuticals do themself now. Everyone for themselves. And information is not being shared within the branche. We have as distributor different agreements, guidelines and demands for each customer. The manufacturers of single-use products, our suppliers, have to make decisions to fulfill these aspects as best as possible. This causes products to become more expensive and delivery times to get longer.
Benefits of standardization
Not only do clear guidelines, but also standardization make it easier to handle quickly. It would be ideal for the end-user if all single-use connectors were interchangeable, without the need to validate again. And with a material choice for sterile couplings we could prevent endless discussions. Through this we guarantee the safety and quality of pharmaceutical processes. It is also beneficial for the price of single-use products.
I do currently see standardization initiatives when it is about single-use assemblies, such as transfersets, consumables and tube sets with certain connectors. When these items are standardized, it will save a lot of production time. Pharmaceutical companies which succeed in making the standardization step, will save costs because they don’t have to perform assemblage work themselves anymore. They could outsource this work to an external party. They also don’t need their own assemblage department if they do this. The plug-and-play products that are made outside of their own facility, have the benefit that you don’t have to autoclave them. You then also save on components that are needed for the autoclaving itself (such as filters). This will therefore cause a decrease in direct and indirect costs.
Around the table
Standardization simplifies the process of the pharmaceutical. The pharmaceutical sector, but also the suppliers, benefit from clarity. But how do we get involved parties around the table? The current situation with the corona epidemic shows that regulations relating to the usage of plastic components and systems in biopharmaceutical processes is needed right now. Parties are now separately determining standards. This fragmentation causes delays and prevents progress. How detrimental that works out is what we are experiencing right now with the long delivery times. No one wants this, especially now when we are trying with might and main to vaccinate the world population to beat the coronavirus.