Single-Use systems that are used for (bio)pharmaceutical processes can be assembled by yourself. This of course needs to happen securely to prevent leakages and (cross-)contamination. The safety of the patient and quality of the medicine may never be overlooked. To prevent risks and production delays, it is also possible to buy single-use assemblies that are ready-to-use. In this blog I will talk about this further.
A single-use assembly is custom-made work
Every single-use application is different. The design of an assembly is therefore always unique for each application. I will explain the process from request to delivery, as we perform it at Hitma, step-by-step.
Step 1: Request of the single-use assembly
To start we search based on the demands, parameters and circumstances of your process which solutions are available for your specific application. At this step we also check for opportunities for standardisation. Through our collaboration with assembly company UltraPure International (UPI) we are able to operate brand-independently and can therefore always completely focus on your application and preferences.
Step 2: Design process
Following the conversations in phase 1, our specialists will create a number of sketches that after your agreement will be converted to official working drawings. In this phase we arrange several aspects with the assembly workers from UltraPure International. On top of this you are welcome on location at UPI in Uithoorn, so you can have a physical assembly that you can verify it yourself. Possible changes to the prototype can be implemented for free.
Step 3: selecting components
When the design is fully according to wishes, we set up a quotation. If this quotation is agreed upon and we receive the order, then this will be directly processed and we will inventarise which components are in stock or have to be bought in. Afterwards the production of the assembly will be taken up into the planning of the cleanroom of UltraPure International.
Step 4: production by UltraPure International
In this phase the operators at UPI start work in their ISO class 7 certified cleanrooms. After production all single-use assemblies are approved according to signed working drawings by our quality control-colleagues.
Afterwards, the assemblies are irradiated. Other bioburden-reduction methods are also possible in consultation. In the meantime, the full Certificate of Conformance (CoC) is set up.
Step 5: delivery of single-use assemblies
Lastly, the single-use assemblies are delivered to your address. They are directly ready for use. Because we are very curious about your experience, we always get in contact with you afterwards.
Benefits of standardising single-use assemblies
Besides outsourcing the assembly-process, you can make another great choice for efficiency. By standardising your assemblies you won’t be faced with surprises when upscaling production. For example, you avoid having to validate new or different components from suppliers.
Every single-use application is different. Designing an assembly is therefore always custom-tailored work.
Keeping delivery times manageable
Standardisation can also help contribute to keeping delivery times manageable. Products that are often used are more often produced than custom-made components. Think also about the choice between standard sizes or new dimensions for each process.
Choosing for standardised components helps to significantly decrease delivery times. This offers primarily benefits for acute requests. Besides that it can be beneficial to standardise based on the material that comes in contact with the product. This is beneficial when validating.
Feel free to come by
I hope that with this blog I have been able to give you an image of the possibilities and benefits of having single-use assemblies assembled by a specialised assembly company. And why it can be a good decision to standardise as much as possible. Want to know more about custom-made single-use solutions for your production process and how we can create these for you? Or maybe you would like to pay a visit to our assembly partner UltraPure International in Uithoorn? Feel free to get into contact with me.