Single-use (disposable) technology is a proven alternative solution for the biopharmaceutical industry offering several significant advantages over standard reusable stainless steel systems, by reducing: Cross-contamination risk Cleaning and associated cleaning validation Capital investment Lead times The number of connections to enhance sterility assurance Furthermore, in applications where hazardous materials are being processed, such as cytotoxic drugs or potent biological materials, closed single-use systems offer additional protection to operators who are isolated from these hazards. Benefits of Single-Use Systems Cost-effective manufacturing technology Single-use systems provide flexibility Technology available at all multiple scales Speed of implementation and time to market Suited for all biopharmaceutical processes Pall's comprehensive single-use product line Unparalleled process knowledge Significant experience of single-use system assemblies Excellence in technical and validation support A Cost Effective Manufacturing Technology While the cost of consumables may be higher, the use of Pall Allegro™ systems can reduce your overall manufacturing costs by enabling: Drastic reduction in chemicals and water for intrusion consumption Lower energy costs through use of gamma-sterilized components Decreased labor with no cleaning or cleaning validation; faster installations and limited QC testing Smaller space requirements for manufacturing

Single-Use Systems Provide Flexibility

Pall Allegro™ systems provide a high degree of flexibility for your process design. They allow you to easily evaluate different configurations before agreeing on the final design. Then, should your batch size be modified, or your requirements evolve, your systems can be easily tailored to fit with your new requirements.

Our technology is applicable to a wide range of unit operations. There will always be at least one step of your process that can benefit from single-use technology.

Technology Available at all Multiple Scales

Pall Allegro™ systems can be used at many scales, from the manufacturing of small, clinical batches to full production scale. Most components are now available at all scales: from capsule filters to chromatography capsules, bags and all related equipment. With consistent materials of construction from small to large scale, single-use systems are ideal for scaling up or scaling down your process.

Speed of Implementation and Time to Market

Pall Allegro™ systems can be developed and implemented in weeks, rather than months. Because of the reduced requirements for validation (including cleaning and sterilization) and the ease of manufacturing, process steps can be developed very quickly. Single-use technology will help you speed up your process development and installation of manufacturing process line, therefore reducing time to market.

Suited for all Biopharmaceutical Processes

Pall Allegro™ systems can be used to manufacture of all types of drugs: monoclonal antibodies, vaccines, gene therapy, recombinant proteins, blood derivatives and anti-cancer drugs. They are particularly well suited for CMOs (Contract Manufacturing Organisations), where a number of different products will be produced and the key issues are flexibility and avoiding cross-contamination. Single-use technology can be applied from upstream through downstream and Formulation and Filling.

Upstream

• Media preparation including mixing, clarification and sterilizing filtration, transfer into bags for storage prior to use
• Sterile sampling

Downstream

• Cell harvesting
• Clarification either with direct flow or tangential flow filtration (TFF) equipment
• Capture with single-use membrane chromatography
• Concentration and diafiltration
• Contaminant removal with either direct flow capsule filters (virus) or membrane chromatography (virus, DNA and HCP)
• Buffer preparation including mixing, clarification or sterilizing filtration, and transfer into bags for storage prior to use
• Sterilizing filtration of bulk and transfer and storage into bags
• Transfer sets including connectors and vent filters
• Sterile sampling

Formulation and Filling

• Preparation of the excipients including prefiltration, sterilizing filtration, mixing, and storage into bags
• Preparation of the final bulk including sterilizing filtration, mixing, and storage into bags
• Filtration sets for connection into the filling line
• Single dose filtration system for the preparation of diagnosis products or patient specific products
• Sterile sampling

Pall's Comprehensive Single-use Product Line

Pall recognizes that single-use systems are becoming the technology of choice for a large number of applications in biopharmaceutical processing. We are focusing our resources on the production of innovative, single-use technologies to serve the market needs.

As a result Pall has the most comprehensive single-use product range to serve all applications from upstream through downstream as well as Filling and Formulation.

Kleenpak™ sterile connectors that allow the sterile connection of two sterile entities in all types of environments

Allegro™ Biocontainers -  a large range of process bags with improved features for connection purposes and drainability

Capsule filters from very small Acrodisc® units to 30-inch Kleenpak™ Nova capsule filters with the widest range of filter media and connection capabilities

Tangential Flow Filtration devices in a variety of configurations to match application requirements: cassettes, Microza hollow fibers, and Kleenpak TFF capsules

Chromatography with single-use Mustang® chromatography capsules for capture and polishing applications

Unparalleled Process Knowledge

As the leading solution provider, over the last decades Pall has been able to create a unique engineering team whose role is to build leading-edge systems for the biopharmaceutical industry. Our Pall Advanced Separation Systems (PASS) team has been involved in the conception, design and manufacturing of simple manual systems to highly sophisticated automated systems which are used throughout the biopharmaceutical industry.

At Pall, we are using this unique organization to help you to design the single-use disposable systems that you need, making sure that these systems will function according to the process specifications and ensure regulatory compliance.

Significant Experience of Single-use System Assemblies

Pall recognized early on the benefits that single-use (disposable) technology could bring to the biopharmaceutical industry. Therefore, over a decade ago and based on our already extensive product portfolio, we established our platform for the design and assembly of single-use systems.

This manufacturing platform for single-use systems allows us to serve our global customer base. We are producing customized non-sterile and pre-sterilized systems that include tubing, connectors, bags, capsule filters, TFF units and more.

Excellence in Technical and Validation support

One of the key elements in Pall’s customer support operations is the Scientific and Laboratory Services (SLS) group. Pall places its extensive technical resources at the disposal of its customers in the form of world-wide technical advice and training, which will help you to efficiently size, design and operate your single-use systems. Pall's Validation Laboratories and Filter Validation Service will assist you to meet regulatory compliance. This can include the FAT (Factory Acceptance Test) and site acceptance of the system, shipping studies, extractable studies and sterilizing filter validation studies.

Comprehensive Documentation Package

Using our extensive experience of supplying systems to the industry, a full documentation package is available with each system in order to help the end user to build appropriate documentary files to ensure regulatory compliance.

Example:

• Certificate of conformance
• Drawings
• Dose mapping report
• Irradiation certificate
• Service/Installation Instructions

Order Process for Your Pall Allegro System

• Contact your Pall representative
• Application and user requirements defined
• Application stability is previewed by Pall technical team (further testing may be required for sizing)
• Drawing submitted for your approval
• System manfacturing (including gamma-irradiation if appropriate)
• Pall Allegro system supplied to your requirements