Kleenpak™ TFF MF Capsules

A Novel Single-Use, Cost-Effective Solution
for Cell Harvest and Cell Clarification

The combination of Pall's single-use technology and tangential flow filtration (TFF) experience has resulted in the development of the Kleenpak TFF MF capsule. This provides a cost-effective, easyto- use TFF module for microfiltration applications such as cell clarification.

Kleenpak TFF MF capsules provide an economical alternative to standard forms of tangential flow filtration. This unique, autoclavable and gamma irradiatable device, consists of dual layered, low adsorption PES membrane available in 0.2 μm and 0.65 μm pore ratings.

Kleenpak TFF MF capsules are available in two sizes. The Mini Capsule (KT1) has 0.06 m2 membrane and is designed for running preliminary tests and optimization trials, before scaling up to the large (KT6) capsule with 0.5 m2 membrane. The large capsules can be manifolded in series and parallel, to increase the effective filtration area.

Kleenpak TFF MF capsules have been validated to ensure reliable performance in the most demanding biotechnology process conditions; they have been engineered to meet the requirements of the biopharmaceutical industry, including resistance to autoclave sterilization and low extractables. Furthermore, because the filter is encapsulated, the user is protected from exposure to hazardous materials.

Features and Benefits

• Self-contained capsule requires no cleaning or cleaning validation
• Housed in polypropylene — no stainless steel housings are required, saving time and capital investment
• Self-contained TFF module — allows for easy installation
• Low hold-up volume conserves precious products
• Manufactured from low extractables material with certification for the current revision of the United States Pharmacopeia (USP) for Class VI - 121 °C Plastics
• Can be connected to disposable tubing, sensors, biocontainers and Kleenpak sterile connectors, to form a complete single-use TFF system, supplied gamma irradiated

Quality Standards

• Manufactured under clean room conditions in a controlled environment
• Manufactured under a Quality Management System certified to ISO9001:2008
• Fluid path materials have been tested and meet the requirements of USP Class VI 121 °C - Biological reactivity in vivo
• Validation tests including:
  • Mechanical tests
    • Leak, burst and creep tests
  • Functional tests
    • Water flow versus differential pressure
    • Autoclave, chemical and gamma resistance
  • Extractables
    • Post autoclave, post chemical and post gamma sanitization

Figure 1

KT1 and KT6 Kleenpak TFF Capsules

Figure 2

Typical Kleenpak TFF MF Capsule System Assembly

Fitting Connections

Capsule/Housing Port Fittings	Size for KT6 Capsule	Size for KT1 Capsule
Feed/retentate	1 – 1.5 in. sanitary flange	0.75 in. sanitary flange
Permeate/filtrate	0.5 in. sanitary flange	0.5 in. sanitary flange

Technical Data⁽¹⁾

Specification	Value for KT6 Capsule	Value for KT1 Capsule
Effective membrane surface area	0.50 m2 (5.4 ft2)	0.06 m2 (0.65 ft2)
Recommended TFF recirculation rate per module	10 L/min(2)	1.2 L/min(2)
Crossflow differential pressure at 20 L/min/m2 recirculation rate	0.3 – 0.5 bar (4.4 – 7.3 psi)	0.3 – 0.5 bar (4.4 – 7.3 psi)
Temperature range	4 – 40 °C	4 – 40 °C
Maximum operating pressure at 40 °C	4 bar (58 psi)	4 bar (58 psi)
Typical operating pressure	< 1 bar (14.5 psi)	< 1 bar (14.5 psi)
pH range	2 – 14	2 – 14
Capsule dimensions (height x diameter), nominal	330 mm x 110 mm (13 in. x 4.3 in.)	304 mm x 110 mm (12 in. x 4.3 in.)

⁽¹⁾ With fully compatible fluids that do not soften, swell, or adversely affect the product or its materials of construction
⁽²⁾ Users can try various recirculation rates for optimal results. The optimum crossflow rate (CF) will depend on the application, cell type, and cell viability, among other factors. The typical operating range is between 10 L/min/m² and 40 L/min/m².

Materials of Construction

Materials of Construction	KT6	KT1
Filter membrane	Polyethersulfone (Supor® membrane)	Polyethersulfone (Supor membrane)
Support and drainage	Non-woven polypropylene	Non-woven polypropylene
Filter end caps	Polypropylene	Polypropylene
Cage	Polypropylene	Polypropylene
O-rings	Silicone elastomer	Silicone elastomer
Core	Polypropylene	Polypropylene
Capsule body	Polypropylene	Polypropylene with TiO2
Capsule head	Polypropylene with TiO2	N/A
Capsule weld strand	Polypropylene with embedded 316L stainless steel	N/A
Center join gasket	N/A	Silicone elastomer
Center join clamp	N/A	Glass reinforced nylon

Figure 3

Yeast clarification using Kleenpak TFF 0.65 μm

Figure 3 shows the scalability from KT1 to KT6 capsules. A sustainable flux was determined for each capsule for the clarification of a yeast culture. Running at the optimized flux clearly shows the stability of TMP during the process, and prediction of throughput can be seen, which is critical for sizing.

Figure 4

Kleenpak TFF MF KT6 Capsules Connected in Manifold