Customized bioprocess container and bag systems

Although our standard Thermo Scientific™ BioProcess Container (BPC) systems can provide the most efficient and economic options for a range of bioprocess applications, we recognize that customized designs may be required due to specific characteristics of a process or facility design.

The wide range of possible options with customized products has a direct impact on their practicality, availability, level of support, and cost. For this reason, we’ve developed an efficient customization Contract Review Procedure compliant to ISO 9001 to help meet your requirements.

Customized bioprocess container product options

There are three main categories of customized BPC assemblies:

  1. Single BPC—The most common custom options are changes to connectors, tubing type/length, and addition of components such as sterilizing filters. A less common additional level of customization involves modifying the standard ports, volume, and dimensions of a BPC chamber to match a specific non-standard outer container.
  2. Tubing Sets—These range from a simple length of tubing with connectors at each end to more complex designs with several branches. They are normally used as accessories to BPC systems to increase the number of connections available or add functionality. Common applications include:
    1. Sampling—A tubing set with several connections allow multiple samples
    2. Filtration—A sterilizing filter connected to an Aseptic Connection Device (ACD) or weldable tubing to allow flexible connection to a BPC
    3. Transfer—Conveying process liquids between holding or process vessels
  3. BPC Manifolds—BPC manifolds consist of a number of BPCs linked together by a spine of tubing and connectors. There is normally a single connection at the inlet of the spine. The most common applications for BPC manifolds are:
    1. Sampling—From a tank or bioreactor where the manifold is likely to include multiple BPCs on the manifold.
    2. Filling—From a process tank or filling machine. The manifold is likely to include larger volume BPCs with one or more smaller QC BPCs on the manifold. The inlet of the manifold would either be a sterilizing filter or a suitable connector.

Levels of customization

Standard products are designed to readily integrate into many bioproduction processes. The level of customization depends on the functionality required, which then dictates the choice of components and the design characteristics of the chambers.

As the complexity and sophistication of the BPC system increases, the time required to fabricate the system and the customer’s commercial commitment increases, too. To simplify the process, custom configurations are divided into two categories:

  • Made to order (MTO)—These designs utilize components from our standard component library. Due to the size and diversity of the standard component library, selection guides are provided to define the available options. The main advantages of selecting this type of customization include a simpler design process, shorter lead times, and greater cost-containment. For these reasons, most custom products are MTOs.

    MTO products are specifically configured using established chamber designs combined with those commonly stocked components from our standard component library.

    Outer support containers are also customizable and involve the stainless steel container systems depicted in this catalog. The scope of outer container MTOs is limited to simple and minor modifications to the fit or finish of existing designs that do not change the internal dimensions or the interface with the matching BPC assembly.

  • Engineered to order (ETO) —These products typically include chambers with unique dimensions, matching a specific outer container, which are not part of our library of qualified and validated designs. Thus our engineering, manufacturing, and validation teams actively participate in the conceptualization, design, fabrication, and qualification of these unique chambers. These chambers are then qualified and validated to meet the established criteria of our standard chamber designs.

    Along with chamber customization, ETOs also encompass those configurations that include non-standard components. Non-standard components may not be accompanied by the same level of vendor-supplied documentation.

    The final ETO category involves customized outer support containers, bins, shippers, racks, and dollies. When major structural modifications to existing or unique designs are required, the ETO-related processes of design, fabrication, qualification, and validation apply.

Custom product procedure

This starts with a discussion with your Thermo Fisher Scientific representative regarding your application and requirements. We’ll advise you of available options and the most suitable choices. Requirements are recorded on a Product Brief Form (PBF), which starts the process.

We then prepare an engineering drawing.

Customer approval is obtained.

Upon customer approval a final price is given.

Order is placed by the customer.
We require an order before manufacturing is initiated or a firm delivery date given.

Product is assembled and irradiated.

Product is delivered to the customer.

By following the seven steps outlined above, your Thermo Fisher Scientific representative will review and provide advice based on your unique requirements. Requirements are recorded on a Product Brief Form (PBF) which starts the process (Step 1).

This process includes preparing an engineering drawing (Step 2) and obtaining customer approval (Step 3) prior to a final price (Step 4). We require an order (Step 5) before manufacturing (Step 6) is initiated or a firm delivery date given (Step 7).

The length of time the entire process takes depends on the complexity of the product, approval time, availability of materials, and current manufacturing capacity. A made-to-order (MTO) product has the shortest and most predictable lead-time. An estimation can be provided during the initial discussion.

BioProduction resources

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