Millipore Pellicon® Mini and Pellicon® Ultrafiltration Systems
| Brand | Millipore |
|---|---|
| Origin | USA |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | Pellicon® |
| Pricing | Available Upon Request |
Overview
The Millipore Pellicon® Mini and Pellicon® Ultrafiltration Systems are engineered for scalable, single-use and reusable tangential flow filtration (TFF) in biopharmaceutical process development and small-scale manufacturing. These systems operate on the principle of crossflow ultrafiltration—where feed solution flows parallel to the membrane surface under controlled transmembrane pressure (TMP), minimizing concentration polarization and fouling while enabling high recovery yields of labile biomolecules. Designed for seamless integration into upstream and downstream workflows, the Pellicon® platforms support both cassette-based ultrafiltration (UF) and diafiltration (DF) across a broad molecular weight cutoff (MWCO) range—from 1 kDa to 1,000 kDa—making them suitable for purification, concentration, buffer exchange, desalting, endotoxin removal, and clarification of diverse biologics.
Key Features
- Modular pump options: Easy-Load peristaltic pumps (CMP1301A, max. 3.4 L/min; XX80EL230, max. 17 L/min) with precise speed control and low-shear fluid handling—optimized for sensitive proteins and viral vectors.
- Sanitary-grade fluid path: FDA-compliant, autoclavable silicone tubing rated for repeated steam sterilization (SIP) at 121°C for ≥30 cycles.
- 316L stainless steel membrane cassettes and holders featuring tri-clamp (TC) connections, polished to Ra ≤ 0.4 µm, compliant with ASME BPE-2022 surface finish standards.
- Pharmaceutical-grade diaphragm valves (1″ or 3/4″ TC) with EPDM or Santoprene® elastomers, validated for clean-in-place (CIP) and SIP protocols.
- Dual sanitary pressure transducers (316L stainless steel diaphragm, TC interface) for real-time monitoring of feed, retentate, and permeate pressures—enabling accurate TMP calculation and process consistency.
- Scalable membrane area configuration: From benchtop R&D (Pellicon® 3 Mini: 88 cm² / 0.11 m²) to pilot-scale processing (Pellicon® 2 Maxi: 2.5 m²; Pellicon® 3: up to 1.14 m²).
Sample Compatibility & Compliance
The Pellicon® systems accommodate a wide spectrum of biopharmaceutical feedstocks—including monoclonal antibodies (mAbs), biosimilars, recombinant enzymes, plasmid DNA, viral vectors (AAV, lentivirus), vaccines (subunit, mRNA-LNP), plasma-derived therapeutics, liposomes, and botanical extracts. All wetted components comply with USP Class VI biological reactivity testing and meet ISO 10993-5 cytotoxicity requirements. The system architecture supports GMP-aligned operations: documentation packages include IQ/OQ templates, material traceability (MTRs), and weld logs for stainless steel assemblies. When operated with validated Pellicon® cassettes (e.g., regenerated cellulose, polyethersulfone), processes may be aligned with ICH Q5A (viral clearance), Q5D (cell substrate characterization), and USP (validation of alternative methods).
Software & Data Management
While the base Pellicon® Mini and standard Pellicon® systems operate via manual or analog control, they are fully compatible with third-party data acquisition systems (e.g., DeltaV, Ignition SCADA) via 4–20 mA or 0–10 V analog outputs from integrated pressure sensors and flow meters. For regulated environments, users may implement electronic batch records (EBRs) with audit trail functionality in accordance with FDA 21 CFR Part 11 and EU Annex 11. Process parameters—including TMP, flux, volume reduction factor (VRF), and diafiltration volume—are manually logged or exported to LIMS-compatible CSV formats. Optional digital pump controllers (e.g., Watson-Marlow 720D) provide RS485 Modbus RTU connectivity for centralized monitoring and historical trend analysis.
Applications
These TFF systems serve critical unit operations across bioprocess development: primary harvest clarification of mammalian cell culture broth; intermediate concentration of purified mAbs prior to chromatography; final formulation buffer exchange for lyophilization or liquid fill-finish; removal of host cell proteins (HCP) and DNA residuals; endotoxin reduction in vaccine intermediates; and sterile-grade pre-filtration of lipid nanoparticle (LNP) suspensions. In academic and CRO settings, the Pellicon® Mini enables rapid DOE studies on MWCO selection, shear sensitivity, and fouling kinetics—providing predictive scalability to production-scale KrosFlo® systems.
FAQ
What membrane cassettes are compatible with the Pellicon® Mini system?
Pellicon® 2 Mini (0.1 m²), Pellicon® 3 Mini (88 cm² and 0.11 m²), all supplied with RC, PES, or PVDF membranes and certified for USP Class VI compliance.
Can the system be sterilized in place (SIP)?
Yes—fluid path components (tubing, valves, pressure sensors, and 316L holders) withstand repeated SIP cycles at 121°C for 30 minutes; validation reports available upon request.
Is the system compliant with FDA 21 CFR Part 11 for electronic records?
The base hardware is Part 11–ready when integrated with validated software platforms supporting electronic signatures, audit trails, and role-based access control.
What is the maximum operating pressure for Pellicon® 3 cassettes?
Standard Pellicon® 3 cassettes are rated for continuous operation up to 4 bar (58 psi); short-term spikes to 5 bar are permissible per manufacturer specifications.
Do you offer installation qualification (IQ) and operational qualification (OQ) support?
Yes—MilliporeSigma provides standardized IQ/OQ protocols, test scripts, and execution support for GMP environments; site-specific risk assessments (e.g., FMEA) can be conducted upon engagement.
