Q: What is a "BPC?"
A: "BPC" is HyClone's acronym for BioProcess Container™. A BioProcess Container, or BPC, is a single-use, flexible, disposable bag engineered specifically for applications in biotechnology and pharmaceutical production.

Q: What are typical applications for BPCs?
A: BPCs are used in single-use manufacturing processes such as media or buffer formulation or filling, bioreactor and fermentation feed and harvest, waste collection, product fractionation, and transport and storage of bulk intermediate and final product.

Q: Why should I use BPCs in my manufacturing process?
A: BPCs provide a single-use, disposable product contact surface. Use of BPCs minimizes the risk of cross contamination that can occur using standard tanks that must be cleaned and subsequently validated for cleaning.

Q: Are BPCs sterile?
A: BPCs are gamma irradiated at a validated range of 25 - 38 kGy to achieve a 10-6 Sterility Assurance Level (SAL). BPC irradiation is based on the current ANSI/AAMI Guidelines for Gamma Radiation Sterilization. A Certificate of Analysis indicating the irradiation dosage that the BPCs have received is provided with each shipment.

HyClone performs quarterly process validations to demonstrate product consistency for particulate matter, endotoxin and adheres to AAMI guidelines. Acceptance Criteria are:

Q: Where are HyClone's BPCs manufactured?
A: All BPCs are manufactured at HyClone facilities under current Good Manufacturing Practices (cGMPs). All critical manufacturing processes take place in Class 10,000 certified clean rooms. Chamber assemblies take place at our Logan, Utah and Novato, California facilities, while final assembly is performed at our Logan, Utah and Cramlington, U.K. facilities.

Q: What sizes are BPCs available in?
A: BPCs are available in sizes ranging from 50 mL up to 1500 L in standard sizes. BPCs can also be configured for individual applications.

Q: I need a different length of tubing and different connectors on my BPC for my application. Does HyClone offer a BPC customization process?
A: While HyClone offers a vast array of BPC sizes and configurations, use of BPCs is process and application specific. HyClone has established a customization BPC program to facilitate the configuration of custom BPCs to fit your requirements and specifications.

Q: Is monitoring of your facility performed?
A: Environmental testing is performed routinely for viable and non-viable particulate in clean room production areas.

Q: What are the components of a BPC?
A: The typical BioProcess Container is manufactured from several components.

• The chamber is the fluid containment portion of the container.
• Tubing used for filling, recirculating, or emptying the chamber is attached to the chamber using ports.
• The tubing end is comprised of fittings.

Q: What are fittings?
A: Fittings are connection devices that allow the end user to access, fill, or evacuate the BPC. Typical fittings for a BPC include luer locks, quick connect/disconnects, or tri-clamp connectors.

Q: What type of film is a BPC made of?
A: HyClone manufactures BPCs with several different films. All pass USP Class VI testing for plastics.

• HyQ® CX5-14, is a 5-layer single-web, 14-mil cast film. The outer layer is made from a durable elastomer resin skin coextruded with an EVOH barrier layer and a polyethylene product contact layer.
  (Click for Additional Information)
• HyQ® CX3-9 film, used in production of HyClone's newest tank liners, is a 9 mil, cast, coextruded 3-layer film. The single web is made from a durable elastomer resin skin, coextruded to a polyethylene product contact layer.
  (Click for Additional Information)
• Attane film is a 3-web multi layer film. The outer web is a coextruded laminate film that supplies a gas and moisture vapor barrier. The inner two webs are produced from an ultra-low density polyethylene. Webs are manufactured as three different layers, then heat-sealed together during the manufacturing process resulting in a BPC chamber.
  (Click for Additional Information)

Q: What is a web?
A: A web is a single sheet of film. A web can be blown or cast, depending on the properties of the film web desired. A web can be comprised of a monolayer (a single plastic resin layer) or a coextrusion (more than one plastic resin layer extruded into a single sheet of film). BPCs can be a single web or multi webs.

Q: What is the difference between blown and cast film?
A: Blown films are produced by extruding molten plastic resin through a small annular die, and then blown upwards to form a large diameter tube. Cast films are produced by extruding molten plastic resin through a slit die forming a flat plastic sheet.

Q: What is the advantage of cast versus blown films?
A: In general, cast films have the following advantages:

• Cleanliness: Cast films are produced in smaller manufacturing areas which minimize the film exposure to the environment.
• Cast film resins may be processed with little or no additives.
• Higher capability of producing uniform gauge films.
• Heavier or thicker gauge films can be produced on a cast process.
• Improved clarity and other material properties.

Q: What testing do HyClone's BPCs undergo?
A: All product contact surfaces are tested for conformance to USP Biological Tests for Plastics, Class VI, as follows:

• Acute Systemic Toxicity
• Intracutaneous Toxicity
• Implantation Test
• Cytotoxicity (Agar Diffusion and Elution)
• Endotoxin level by Limulus Amebocyte Lysate (LAL)
• Heavy Metals Concentration
• Buffering Capacity
• Non-volatile Residue
• Residue on Ignition

In addition to the USP testing, HyClone performs European Pharmacopoeia (EP)Testing as follows:

• Appearance, Acidity and Alkalinity
• Absorbance, Reducing Substances
  

Physical Properties tested are:

• Film thickness (mil)
• Film Vapor and Gas (O₂ and CO₂) Transmission Rates
• Film and Tubing Tensile Properties
• Seal Integrity of Film and Tubing/Fittings

Q: What type of incoming inspection is performed on BPC components?
A: BPC Raw Materials Component Parts are inspected according to individual component specifications, which typically include visual and dimensional inspection. Films are inspected for contamination; gels or carbons; dimensions including film thickness; tensile strength and elongation; and chemical composition by FT-IR spectrometry.

Q: Are there any in-process inspections performed during BPC production?
A: BPC Chambers are tested during the manufacturing process and inspected for the following:

• Appearance (Defects or contamination)
• Seam and port seal strength
• Dimensions (Overall chamber dimensions, port and hanging tab location)
• Hydrostatic testing (minimum strength properties of port flange seams) according to statistical proces control sampling plan
  

Finished assemblies are inspected for correctness of parts, completeness, particulate debris, defects and damage, correct packaging, and hydro-burst testing according to statistical process control sampling.

Q: What are the release criteria for BPCs?
A: Once final product inspection is performed and BPCs have been irradiated, the production lot records are reviewed by Quality Assurance for completeness and correctness prior to the release of the lot. All sections of the lot record are reviewed including Bill of Materials, Certificate of Irradiation, Production Inspections, Production Integrity Testing, Labels, and Certificate of Analysis.

Q: Can BPCs be frozen?
A: HyClone's small volume BPCs of HyQ® CX5-14 film (< 20 L) have been validated for -80°C applications. Care should be taken when handling frozen BPCs due to the fragile nature of the tubing connected to the bag when frozen.
(Click here for frozen handling instructions).

Q: Can the containers be retrofitted into my existing system?
A: Yes, the BPCs are available that fit most existing bioprocess vessels such as Nalgene and Chemtainer industrial standard size cylindrical drums. Custom configured BPCs are also available.

Q: Does HyClone provide the outer containers?
A: Yes, HyClone has developed and provides fully validated outer containers for in house transportation and on site shipping.