Quelle standardisation pour les technologies Single-Use ?
L'article suivant a été publié le 17 juin 2013 en anglais sur le site de l'A3P.
Resins used to make single use technology open the mind of the design engineering, and give the opportunity to suppliers and to the final users to improve and increase their business. The power of this new way of doing push to use disposables in every step of a process and it is hard to imagine that this will change soon. We even try today to build a completely closed process with Single Use items. However, the industrial requirements from each side, supplier and user, claim to have more standardisation in order to be able to have a better control on their products.
Innovation limits in the Single Use market
Very logically, facing this new market, suppliers want to distinguish themselves from the others in proposing innovating technologies, that match together to form several technological packages (tubing systems, purification systems, sample taking systems...). Indeed, each supplier provides full compatibility for its own different items, but not always with their competitors...
Different aspects of Single Use technologies can, in some cases, slow down their acceptance by final users (the list is not exhaustive):
- The price of Single Use items. Depending of the company needs, of their production type, Single Use prices can represent a real obstacle, combined to the need to be sure of the reliable efficiency of the Single Use items.
- The delivery time. Disposables have expiry dates and somehow their production follows rules of "consumables". It is difficult to have a clear view of the demands of the market, suppliers try to ensure it with doing standard product, several years purchase contract, but this is not enough and users have always to be aware about the delivery time that can take more than 8 weeks.
- The ability to determine extractables & leachables from Single Use item in the final product. With more and more performing technologies permitting to detect particles of increasingly smaller, we may discover such things in actual products from Single Use process.
- The training of operators, who face an important quantity of different instructions, depending on the specificity of each supplier. The learnability of Single Use technology is critic for the good use of the material, the safety of operators and the quality of the final product.
These problems can be minimized with a better and common knowledge of the Single Use system that leads to standardization.
From a supplier point of view
The standardization, regarding to this logic, is not encouraged:
- It helps competitors and increases competition
- It helps new entrants getting into the market
- It decreases product distinction
- It decreases brand loyalty
The main risk with standardization is to kill innovation. Indeed, what makes suppliers distinguish from another is its ability to provide innovation with its items, its specific technology. Standardizing may inhibit innovation in forcing suppliers to reduce their flexibility.
From a final user side
Final users of Single Use technologies are in front of a wave of suppliers providing different systems, claiming that their specific one is better than competitor's. Final users spend a lot of time and money in comparing, assessing the items of different suppliers instead of buying what they know they need, making product that makes profit and allows them to buy more equipment.
Furthermore, when they do their choice, users depend on the supply chain risks of their supplier. They have to work on different strategies to ensure their needs. In the end it doesn't erase the possibility to see a rupture because of several reasons:
- Supplier bankrupt
- Change of the raw material coming from their own suppliers of resin
- Problem with transport sub-‐contractor
However innovation is essential to reduce disadvantages of Single Use technology facing Stainless technology (increasing flowpath, security, reducing leachable). And innovation is a key factor that can lead to innovating products or processes, essential to the viability of the final user on its own market.
What solution for standardization keeping innovation ?
Standardization must not be a brake to innovation. To assure that, applying standardization must not be just rules to accommodate first needs of users, like a specific type of connector or a specific flowrate. What should be done is a quality-‐by-‐design list of acceptance criteria to assess each component of a disposable assembly. It would permit final users to analyse, according to their specific needs, criteria like:
- Mechanical compatibility
- Functionnal characteristics (pressure rating, temperature...)
- Sterilisation methods (what the material can withstand, characteristics post sterilisation...)
- Extractable and Leachable
- Impact of packaging components
- Safety data package
- Packaging and transport validation
Such standard list would be built according to what is widely recognized and/or employed because of the excellence of the results from the combined systems, in order to put in place closed, sterilised and secure assembly.
It should be flexible enough to permit innovation going on.
This kind of standard reference work would be legitimate, because constantly challenged by scientific discoveries in Single Use technologies.
What that can be standardize concerns the different technical approach and controls about Single Use processes, like:
- Approaches to sterilization,
- Characterization of Extractable and Leachable,
- Particle and endotoxin testing,
- Tubing ID,
- Hose barb,
- Flange dimensions,
- Skid and platform that can fit with different supplier consumables,
Also, standardized change control strategy could be done for:
- Extractable and Leachable of new material introduction,
- Supply chain risk assessed,
- Scale limits,
- Environmental impact,
Such system could help identify more efficiently the pros and cons of each Single Use system, combined to the system's idiosyncrasy. But this does not concern all the different aspects of the system that are specific and essential in its way to work and innovate.
Regarding the regulatory status, it is especially important to demonstrate that good manufacturing practices are followed, and that the safety/traceability of the final product can be validated, instead of monitoring a standardized process.
The future is still to be built and the 3D printing can offer few solutions that can help in very personalized innovation and minimize risks previously mentioned as supply chain...To be continued...
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Malik BELATTAR, CEO & Project Manager, Pharma Biot'Expert
David‐Alexandre BADAROU, Project Engineer in Biotechnology, Pharma Biot'Expert