Pharma Positively Charged Nylon 6,6 Cartridge Filters0 pages
PNC Cartridge Filters
Positively Charged Nylon 6,6 Membrane
Diagnostics
Dialysis Applications
LVPs and SVPs
Biologicals
Water for Injection
Endotoxin Reduction
Integrity Test Specifications
Per 10-in. length, water-wetted membrane
Pore Size
0.10 μm
Filtration Media
Positively Charged Nylon 6,6
Membrane
Media Support
Polypropylene
End Caps
Polypropylene
Center Core
Polypropylene
Outer Support Cage
Polypropylene
Sealing Method
Thermal Bonding
O-rings
Buna, Viton® (or FKM), EP, Silicone,
FEP Encapsulated Silicone, FEP
Encapsulated Viton (or FKM)
Note: All materials of construction are FDA accepted. Final assemblies have
been validated to pass USP Class VI toxicology extractable tests, oxidizable
substances for plastics, endotoxin level, and other quality tests.
Dimensions
Length
5 to 40 in. (12.7 to 101.6 cm) nominal
Outside Diameter
2.75 in. (7.0 cm) nominal
Filtration Area
7.0 ft2 (0.65 m2) per 10 in. length
< 15 cc/min at 35 psig (2.4 barg)
0.45 μm
Construction Materials
< 15 cc/min at 48 psig (3.3 barg)
0.22 μm
PNC Membrane Filter Cartridges are sterilizing grade cartridges
with charged Nylon 6,6 membrane. The nylon membrane used in
these cartridges is positively charged for enhanced retention of
particles below the rated pore size of the filter. Nylon cartridges see
broad service in sterile fill applications in SVPs and as bioburden
management filters in LVPs. Media preparation and service liquid
filtration are other common applications for this cartridge. Positively
charged nylon is particularly suited for endotoxin removal in water
systems. Nylon is also used for filtration of solvents because of its
broad compatibility and low level of extractables.
Air Diffusion Rate
< 15 cc/min at 20 psig (1.4 barg)
0.65 μm
< 15 cc/min at 15 psig (1.0 barg)
Maximum Operating Parameters
Differential Pressure
•t Forward
50 psid (3.4 bard) at 20 °C (68 °F)
•t Reverse
40 psid (2.7 bard) at 20 °C (68 °F)
Operating Temperature
Recommended
Changeout Pressure
82 °C (180 °F) at 10 psid
(0.69 bard) in water
35 psid (2.4 bard)
Sanitization/Sterilization
Filtered Hot Water
90 °C (194 °F), 30 minutes, multiple
cycles, max 3 psid forward flow
Autoclave
121 °C (250 °F), 30 min, multiple cycles
In-line Steam
135 °C (275 °F), 30 min, multiple cycles
For all elevated temperature procedures above, a stainless steel
support ring is required.
Chemical Sanitization
Nylon does not tolerate aggressive chemical sanitization
protocols. Nylon membrane cartridges are best sanitized with
1% hydrogen peroxide or 1% hydrogen peroxide and peracetic
acid. Various manufacturers use different concentrations of
active ingredients. Refer and adhere to the manufacturer’s
instructions for sanitizing nylon membrane.
Endotoxin Removal
PNC filters removed up to 99.9% of endotoxin when challenged
with between 3EU/ml and 240EU/ml.
Pharmaceutical Grade
Applications
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