Material Qualification Dossier
Quality Management Dossier (Open Access)
|When a Pellicon Holder is ordered, what do I receive?||The holders are supplied with a socket wrench, 3/4" sanitary clamp adapters, clamps, and gaskets. The pressure gauges need to be ordered separately by ordering catalog number XX4200075. Only one 0- 100 psi analog gauge is supplied with this number, and it is recommended to operate with two gauges, one for the feed and one for the retentate. Conversely, order the appropriate Pellicon fitting kit which contains the pressure gauges, fittings, clamps, and valves for connecting the pump to the holder.
|Are the TFF membranes autoclavable or steam sterilizable?||The membranes for Pellicon® 3 cassettes are not autoclavable or steam sterilizable. However, a chemical sanitization can be done; refer to the user guide for recommendations.|
|Cogent μScale Tangential Flow Filtration System User Guide|
|Pellicon® 3 Cassettes - Installation and User Guide|
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|Biopharmaceutical Manufacturing > Downstream Processing > Ultrafiltration > Pellicon Cassettes > Pellicon 3 Cassettes|
Advanced, high-performance cassettes ideal for today’s higher titer therapeutic antibodies as well as the more demanding filtration processes require higher operating pressures, temperatures and caustic cleaning regimes.
Pellicon® 3 cassettes with Ultracel® membranes are the optimum tangential flow filtration devices for the filtration of monoclonal antibodies and other therapeutic proteins.
Pellicon® 3 cassettes with Biomax® membranes are the optimum tangential flow filtration devices for the filtration of solutions containing albumin, hormones, vaccines and growth factors.
Pellicon® 3 Cassettes are favorites in both laboratory and large-scale production environments and come loaded with your choice of the following leading-edge membranes:
- Ultracel® Membranes – designed for the filtration of therapeutic proteins (such as monoclonal antibodies) and recombinant and non-recombinant proteins.
- Biomax® Membranes – perfect for the filtration of monoclonal antibodies and solutions containing albumin, hormones, vaccines and growth factors.
Choice of feed channel turbulence promoting screens to best match your process requirements:
- A Screen (tight screen)
- C Screen (coarse screen)
- D Screen (coarse screen for high viscosity)
- Rugged & reliable – ideally suited for today’s more demanding filtration processes
- High performance – produces excellent resolution, yields and back-pressure resistance.
- Optimum product recovery – thanks to proven membrane technology
- Void-free technology – leading-edge membranes resolve virtually any separation challenge
- Defect-free, superior adhesion – Ultracel®uses composite membranes cast on a microporous substrate
- Automated manufacturing – delivers unbeatable performance, consistency and reliability
- Easy installation & care – simple to install and maintain
|Materials of Construction|
|Ultracel® Membrane:||Composite regenerated cellulose|
|Assembly Design:||Automated assembly and testing of heat-sealed packets bound together by an injection molded polypropylene jacket.|
|Component Material Toxicity:||Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics.|
|Good Manufacturing Practices:||These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.|
|ISO® 9001 Quality Standard:||This product was manufactured in a facility whose Quality Management System is approved by an accredited registering body to the appropriate ISO® 9001 Quality Systems Standard.|
|100% Integrity Tested in Manufacturing:||Each unit must pass an integrity test based on air flow through the fully-wetted membranes of the filter.|
|Validated Production Process:||This product was fabricated using a validated manufacturing process. Principles of statistical process control and determinations of process capability have been applied to critical variables in the device fabrication process. In-process controls are used to assure stability of the process.|
|Pellicon® 3 Cassettes with Ultracel Membrane||Pellicon® 3 Cassettes with Biomax Membrane|
|Recommended Feed Flow Rate||4 – 6 L/min/m²||4 – 6 L/min/m²|
|Maximum Operating Pressure/Temperature||80 psi (5.5 bar) TMP @ 40°C (initial use)
40 psi (2.7 bar) TMP @ 50° C
|80 psi (5.5 bar) TMP @ 40° C (initial use)
40 psi (2.7 bar) TMP @ 50°C
|Maximum Reverse Pressure||30 psi (2 bar) ) @ 25°C for 24 hours||30 psi (2 bar) @ 25° C ) @ 25°C for 24 hours|
|Maximum Caustic Concentration||0.5N NaOH @ 50°C up to 50 hours||1.0N NaOH @ 50°C up to 200 hours|
|Operating pH Range||2 – 13||2– 14|