FAQ

We understand that there can be quite a few questions when manufacturing custom assemblies. On this page we have bundled a large number of frequently asked questions. Is your question not listed? Then your local partner will surely be able to help you find the answer.

Knowledge
  • What is MOQ?

    Minimum Order Quantity

  • In what country is your cleanroom located?

    As UltraPure International, we are located n the Netherlands. For rapid response purposes we can also support you from our facility in Sweden

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  • Do you make drawings?

    Yes, our drawings are our specifications and are made by our dedicated engineering team (Solution Design).

     We do not produce Single Use assbemlies without an approved drawing.

  • What is Ultrapure International?

    UltraPure International is a production company, focussed on high-end single-use assemblies for the (bio)pharmaceutical industry.

    This is done with a high knowledge of Single Use components and the applications that the assemblies/manifolds are used in. We produce for our exclusive partners within the Indutrade group, which will be your local contact point. This means that we think global and act local. 

  • What is the difference between gamma irradiation and sterility?

    The difference is big and small at the same time. Both will go through the same instructions for gamma irradiation.

    The difference is that for the Sterility Assurance Level 10^-6 (SAL10^-6), we need to prove that that the assembly falls in our steriltiy programm, or can be adopted into it. 

Lead times / Shelf Life / Stock
  • What is the lead time?

    It depends on component availability and production time availability. We have increased our production capacity and have also increased our stock.

    Lead times can be reduced with increased flexibility in component selection. We strive to meet a 12 week lead time. 

  • What is the leadtime for drawings?

    If standard components are used, leadtime of an assembly will be in between one to seven days.

    With the future usage of a new program, we are able to configurate drawings at the table, giving you a direct budget quote and drawing.

  • What is the shelf life of the assembly?

    The expiry data as defined on the labels of the UltraPure International assemblies are based on the following principles:

    • Components integrated in an assembly should have a remaining minimum shelf life of one year after date of manufacturing of the assembly.
    • UltraPure International is only using original shelf life statements as issued by the original manufacturer. UltraPure International is not performing any shelf life / aging tests by herself.
    • Post gamma shelf life statement of a component is leading
    • Standard shelf life statement of a component will be used when no post gamma shelf life is available.
  • What is the shelf life after gamma irradiation?

    The expiry data as defined on the labels of the UltraPure International assemblies are based on the following principles:

    • Components integrated in an assembly should have a remaining minimum shelf life of one year after date of manufacturing of the assembly.
    • UltraPure International is only using original shelf life statements as issued by the original manufacturer. UltraPure International is not performing any shelf life / aging tests by herself.
    • Post gamma shelf life statement of a component is leading
    • Standard shelf life statement of a component will be used when no post gamma shelf life is available.
  • Can you ensure that we will not have a production stop due to delivery problems?

    For the first order, we depend on the delivery time of the components.

    However, any follow-up order for after that, we can keep stock and therefore produce on time, provided this is indicated in time.

  • Will you have the parts on stock for us?

    Yes, we are able to do so, under contract.

  • How quickly can you start producing?

    It depends on component availability and production time availability. We have increased our production capacity and have also increased our stock.

    Lead times can be reduced with increased flexibility in component selection. We strive to meet a 12 week lead time. 

  • How fast can we get a prototype and/or sample?

    We carry a wide variety of stock. However, if there is one part of the Bill of Material not directly available this will elongate the leadtime.

    If we are able to exchange this for an equivalant component in stock we are able to meet very competitive lead times. 

Packaging
  • Can you send an example document package?

    Yes.

    Our documentation package consists of a Certificate of Conformence (CoC), and a Certificate of Irridiation (CoI), if any extra tests are performed, we will combine the CoC and the CoA (Certificate of Analysis). 

  • How are the assemblies packaged?

    As a standard we package all our assemblies double bagged in our cleanroom, after which they receive a label and go through a 100% QC control.

    Our warehouse then packs the assemblies according to specific instructions, to comply with the instructions for gamma irradiation. 

Preparation

Pricing
  • What is the price?

    All our assemblies are custome made specifically for your applications and demands.

    For any prices please contact your local partner. 

Security & Quality
  • Can you customize to our needs?

    Yes, we are specialists in custom-made assemblies.

  • Can we get certificate a,b,c etc.?

    Every assembly we produce comes with a Certificate of Conformance and a Certificate of Irradiation (if applicable).

    When you need an extra or digital copy, we always keep them on file until the length of days (minimum of 10 years). 

  • Which ISO class are your cleanrooms?

    We have multiple manufacturing locations.

    Uithoorn (The Netherlands): ISO Class 7 in production

    Cork (Ireland): ISO Class 7 & ISO Class 8

    Ghangzhou (China): ISO Class 8 in production

  • How can we secure delivery in time?

    Due to shortage in the world of raw materials, and therefore the final product, you need to order timely.

  • Can you supply BSE/TSE Animal derived free certificate?

    We have an open architecture approach, so if the customer requires it is possible. But it’s necessary to inform beforehand.

  • Can you supply CoC with USP Class VI?

    No, not right now. However, we can supply a separate document with USP Class VI.

  • Can we introduce our own parts to the assembly?

    We ensure all components that go into our cleanroom meet the highest standards, so that we can ensure no contamination will take place.

    If proof can be given that the “own parts”  conform to our standards and that you have a quality system in place that will inform us correctly, we will be able to include. 

  • Do you sterilize your single use systems?

    It’s important to know the difference between gamma irradiated and sterility.

    The majority of our assemblies are gamma irradiated, which means there will be a log reduction of the bioburden count. However, in order to claim sterility (requested by your customers) you will need to validate the so called sterility assurance level, also often written down as SAL10-6 . We have a sterility program in place and based on the components, amount of connections and the total surface area we are able to claim a SAL10^-6 on the entire assemby or fluid path only.

    To summarize there are three different options:

    • Gamma irradiate (standard)
    • Sterility claim
    • We package the assemblies in autoclavable bags.
  • Do you sterilize yourselves or do you work with an external partner?

    Our standard is gamma irradiation.

    A high level of expertise is needed to conduct this correctly and in a safe way, as Cobalt65 if officially radioactive material. Therefore, this step in our process is done by an external partner of UPI, Steris.