A complete MilliporeSigma Cogent CPS Size B Tangential Flow Filtration skid — built new for Novavax/AGC, never field-deployed in long-term production, equipment ID FLT0347719. Self-contained TFF process skid: bring your own tank. Tier-1 components throughout (Quattroflow, Watson-Marlow, Endress+Hauser, Optek-Danulat, Allen-Bradley, MilliporeSigma, GEMÜ, LABOM), full 1,649-page turnover package, all cal certs and MTRs in hand.
Exceptionally well maintained and well documented Novavax surplus. Complete, fully documented, GMP-grade fluid processing skid (minus tankski), with high-end pump, mixer, valve network, instrumentation, and full engineering + QA traceabilit
Placed out of service 22 October 2022 per AGC Biologics decommissioning record CR-02753.
Decommissioning included full certification per GMP standards.
Includes complete original comprehensive turnover package (5,269 total pages)
- Also includes original General Arrangement drawing and complete Electrical Wiring Diagram package (75 pages) from system integrator Holland Applied Technologies.
- The tank skid shown in the drawings is not included. The EWD and turnover docs contain exhaustive, precise, detailed documentation for your engineer to integrate your own tank skid and/or bypasses to your precise process needs.
Included Configuration
(See markup in photos)
Option 2: Low volume bypass
This option is used to minimize the recirculation volume, avoiding introducing air in the line, which could damage proteins or create foam. The retentate recycle will start to be used as soon as the level in the tank will go under the retentate return pipe. The option is mainly required when a customer tank is connected to our skid with flexible hoses or if maximum concentration is needed. Note: Tank Outlet Level Switch is required when using the tank recycle to allow efficient final concentration step.
Option 3A: Peristaltic transfer pump with inlet manifold
The transfer of product / buffers into the feed tank from any other tank. The manifold allows connecting several inlets at the same time, avoiding several connections/disconnections.
Option 5: Feed mass flowmeter
Option 7: Filtrate conductivity
Measurement of a wide range of products (WFI, buffer solutions, protein solutions) or post CIP flushing monitoring.
Option 11: Filtrate UV
Measurement of a wide range of products (WFI, buffer solutions, protein solutions) or post CIP flushing monitoring.
Option 15: Pellicon® Holder with control box
The Pellicon® Process-scale Holder is uniquely designed to reduce the time required to install and remove TFF devices for production scale while keeping the flow path unchanged. The holder can be configured either with manual or hydraulic closure. Hydraulic closure can be done with a hand pump or with an automated hydraulic box which allows local or distant control.
Benefits:
• Compact footprint
• TFF devices can be installed/removed quickly
• Easy to vent and fully drain, maximizes product recovery
• Easy retrofit from manual to hydraulic closure
• Flow path unchanged, minimizes future re-qualification and validation effort in new process application
Option 16: Filtrate mass flowmeter
Filtrate flow and total volume monitoring in diafiltration mode
Option 18: Retentate and filtrate NovaSeptum® sampling port
In process sterile sampling of product.
NovAseptum® sampling consumables have to be ordered separately.
Option 25B: Connection to customer UPS
External power supply to prevent data lost in case of power supply failure . All the power components like pumps, mixer, etc... remain connected to the main power supply during 15min, the time for operator to safely turn off the system
EMBEDDED NOVASEPTIC® VALVES AND MIXER:
• Comply with cGMP Design Qualification criteria for aseptic processing.
• NovAseptic® connector ensures no dead legs and maximum product recovery with zero hold up volume
• Comply with the most stringent cleanability and sterilizability requirements.
• Mixer is clean running and is suitable for general mixing, heat transfer and shear sensitive applications.
• Reduced bioburden.
• Lower cost of maintenance.
• Mixer new diamond coated bearings ensures long life and optimum performance.
• Ability to mix the “last drop”, ensures complete product recovery.
PROCESS CONTROL:
The Cogent® Process Scale Tangential Flow Filtration System is easilly controlled via the Common Control Platform® (CCP®) a powerful, intuitive, graphical software interface that provides real-time monitoring and total in-depth control of your TFF process. Using industrially robust PCs, PLCs and SCADA® technology it meets the most stringent standards for connectivity, reliability and ease of use. Benefits :
• Create process operations using the recipe editor, monitor or control the process in the home screen and create reports for the batch using the configurable report generator.
• Developed under GAMP guidelines and FDA 21CFR Part 11 compliance-ready, including audit trails and electronic signatures for verification.
• Sensors combination can be adapted to process requirements allowing the maximum confidence in process monitoring.
• Utilities to connect all of your separation unit operations to a central network or DCS (e.g. Delta V).
• Used on multiple unit operations CCP provides one familiar interface to simplify software management and reduce learning curves.
Built for vaccine manufacturing
1. OEM pedigree. This is a Millipore-built CPS — MilliporeSigma's flagship process-scale TFF platform.
2. Built for vaccine manufacturing. Original end user was Novavax (PO2000850), built through AGC Biologics as integrator. Phase III / commercial-grade vaccine pedigree
3. The Pellicon TFF holder. MilliporeSigma PEH1150HHPT4 — Millipore's premium hydraulic-compression Pellicon cassette holder, 1.5" TC, 316L body, EPDM gaskets. The full hydraulic intensifier system is included (Interface Devices H030/30-00PM-1GA, NoShok 0–3000 PSI gauge, GEMÜ ePos 1435 intelligent positioner driving cassette compression at 0–138 barg).
4. Bring-your-own-tank flexibility.
5. Complete documentation package. 1,649-page ETOP — mill test reports, calibration certificates (LABOM, Optek, Mettler Toledo, Endress+Hauser), QC release certs, software install procedures, electrical drawings, P&IDs, PLC program. Buyers in pharma will pay a premium just for the docs because re-qualifying without them is brutal.
6. Fully automated, ready to validate. Allen-Bradley PLC + Siemens HMI, two PowerFlex 70 VFDs for both pumps, full instrumentation suite.
Hard-spec talking points
Process pumps:
- Feed pump (P-001): Quattroflow QF10KACU 4-piston piston-diaphragm, 2" TC, ~10,000 L/h, 6 barg max. S/N 816665. The gold standard for shear-sensitive biologics.
- Transfer pump (P-401): Watson-Marlow 701FB peristaltic, paired with NORD SK 90SP/4 motor (1.5 HP / 1.1 kW, IE3, IP55 TEFC, S/N 34597744)
TFF & hydraulic compression system:
- MilliporeSigma Pellicon hydraulic-compression cassette holder PEH1150HHPT4 (1.5" TC, 316L, EPDM gaskets) — the centerpiece
- Interface Devices H030/30-00PM-1GA hydraulic intensifier (air → 3000 PSI), S/N 20-0338-HY, install date 6/30/20
- NoShok P12-5674 hydraulic pressure gauge, 0–3000 PSI
- GEMÜ ePos 1435 intelligent valve positioner (PY-001), S/N 88092764
- LABOM hydraulic pressure transmitter (PIT-501)
- MilliporeSigma HB-501 hydraulic box (HA87110), 0–138 barg operating
- MilliporeSigma CIP/SIP Plate (PEH0PTCIP1)
Coriolis flow measurement (2 units — major value):
- FT-001: Endress+Hauser Promass F 100, 8F1B40-4L08/0, DN40 (1.5"), 4–20 mA = 0–330 lb/min, HART, S/N R700DC16000
- FT-101: Endress+Hauser Promass F 100, 8F1B25-5NJ9/0, DN25 (1.0")
Process pressure instrumentation (LABOM throughout):
- PT-002, PT-003, PT-101 — LABOM CC6010 family sanitary pressure transmitters with DL3230 diaphragm seals
- PIT-001, PIT-401 — LABOM CS2110 family
- Asset IDs PTX0365, PTX0366, PTX0367, PTX0371
Optek-Danulat analytical:
- AE-101: F20 UV/VIS absorption sensor body, 1" TC, 8mm flow cell, S/N 108986 — body 0120-2911-33, MS3 8M5 sapphire optics, AF45-VB module, 10m cable
- AE-102: F40 inductive conductivity sensor, 1" TC, S/N 107905 — body 0120-2918-33, ACF60-35-22 sensor, 10m cable, integral RTD (TE-101)
- AIT-101: Optek C8480 dual-channel UV+conductivity+temp transmitter, 24V AC/DC, S/N 108489
Process valves & sanitary fittings:
- GEMÜ 650 40D59401723T1 SF5 sanitary diaphragm control valve
- 4× PBM SIHL sanitary manual ball valves (HV-203/204/206/207, 0.75" and 1" BW)
- PBM XV-205 actuated ball valve
- Swagelok SS-CHS8-1/3 check valve (CV-602), Swagelok HV-501
- Kunkle/NASVI 911BDCM01-AJE sanitary safety pressure relief valve (PRV-202)
- BS&B 1.5" GCR-SM rupture disc (BD-201), 3 bar burst @ 50°C, includes 2 spares
- LJ Star sanitary sight glass + light
- Kodiak Controls KC302D15860 mechanical pressure gauges
- TECMAQ Tri-Clamp adapters (104968, 55358, 71028228)
- ~50+ NEUMO MaxPure 316L electropolished sanitary fittings (elbows, tees, ferrules, reducers, 0.5"–2.0")
- Sandvik 21.3 mm OD seamless 316L tubing
- Watson-Marlow Pumpsil 913.A254.PFT silicone flex hose (×2)
- HAT silicone flex hose set
Pneumatics:
- SMC PCV-601/602 filter+regulator combos
- SMC HV-601/602 manual pneumatic shut-off + lockout (VHS40-N04B-Z)
- SMC ISE40A-N01-Y-PK-X531 digital pressure switch (PISL-601)
- SMC XV-601 solenoid
Controls — enclosures:
- Saginaw Controls SCE-60EL3616SSLP main enclosure, 60×36×16, 304SS Type 4X IP66
- Saginaw Controls SCE-60P36 back panel
- Saginaw Controls SCE-24EL2008SS6LP sub-enclosure, 24×20×8, 304SS Type 4X
- Siemens SIMATIC HMI door touchscreen
- Allen-Bradley 194R 30A fused 480V door disconnect
- Allen-Bradley 194E 16A 120V UPS load switch
- 3× Mersen 480DB1 25A 480V distribution modules
- Phoenix Contact QUINT 24VDC 20A power supply
Controls — PLC & I/O:
- Allen-Bradley CompactLogix 1769-L33ER PLC
- 2× Allen-Bradley PowerFlex 70 VFDs (matched-set, sequential serials):
- SIC-001 Feed pump drive: 20AD8P0C3AYNAEC0, 5 HP / 4 kW, S/N 80797724
- SIC-401 Transfer pump drive: 20AD3P4C3AYNAEC0, 2 HP / 1.5 kW, S/N 80797722
- Both with 20-COMM-E EtherNet/IP adapters
- Murr Elektronik Cube20 BN-E EtherNet/IP head + 6× Cube20 A14 4-ch analog input modules
- SICK FLEXI Soft safety controller (CPU0 + 2× XTIO)
- Allen-Bradley safety relay
Materials/finish:
- Every wetted surface 316L SS, electropolished to ≤20 Ra Max + EP
- Some lines down to <0.4 µm Ra (Optek bodies)
- USP Class VI EPDM elastomers throughout
