206958 DF_RTP_NFF

RTP ULTA Pure SG capsules
Pleated Capsules with Sterilizing Grade Polyethersulphone
Membranes RTP ULTA Pure SG capsule utilizes the
special properties of a patented microbially retentive
polyethersulphone membrane to provide sterile filtration
to meet the specific needs of the pharmaceutical industry.
Features
• Gamma compatible
• Microbially retentive and validated to ASTM F838-83
methodology
• Asymmetrical pore structure resulting in high throughputs
and flow rates
• Low protein binding characteristics
• Wide range of chemical compatibility with low
extractable levels
Materials of construction
• Polyethersulphone membrane
• Polyester support layers
• Nylon housing and components: cage and core
• Nylon end caps
RTP ULTA Pure HC capsules
Pleated Capsules with Polyethersulphone Membranes
RTP ULTA Pure HC capsule filters have been specifically
designed for the effective and economical processing
of difficult to filter solutions often associated with
biopharmaceutical production.
Features
• Optimized membrane configuration allows up to ten
times the throughput
• Integral prefilter layer minimizes areas for greater
processing economy
• Correlated integrity test assures sterility
• Low adsorption of proteins for minimal loss of expensive
pharmaceutical product
Materials of construction
• Polyethersulphone membrane over
Polyethersulphone prefilter layer
• Polyester support layers
• Nylon housing and components: cage and core
• Nylon end caps
Recommended capsule
operating conditions
Up to 70°C (158°F) continuous operating temperature
and higher short-term temperatures:
Maximum
Maximum
Temperature forward dp reverse dp (1)
(ºC) (bar) (psi) (bar) (psi)
20 5.0 72 2.0 29
40 4.0 58 1.5 22
60 3.0 44 1.0 15
80 2.0 29 0.5 7
90 1.0 15 not recommended
Capsules may be operated up to a temperature of 40°C (104°F) at line
pressures up to 5.0 bar (72 psig) for liquids and 4.0 bar (58 psi) in air/gas
Biological safety
Materials conform to the relevant requirements of 21CFR
Part 177 and current USP Plastics Class VI - 121°C and
ISO10993 equivalents.
Non-volatile extractables (NVE)
Total NVE’s extracted in the first five liter flush of WFI for
a 6 inch equivalent gamma sterilized device is < 5 mg.
Oxidizable substances
RTP ULTA Pure HC and SG capsule products meet current
USP quality standards for oxidizable substances.
TOC/Conductivity
The effluent quality from a 6 inch equivalent RTP ULTA Pure
HC and SG capsule device conforms to the requirements of
USP 28(TOC) and USP 28 (conductivity) following
a three liter flush.
Endotoxins
Aqueous extracts from the RTP ULTA Pure HC and SG capsule
products contain < 0.125 Eu/ml when tested in accordance
with the standard LAL test.
Retention characteristics
RTP ULTA Pure SG and RTP ULTA Pure HC capsules are
validated to give an LRV of at least 7 when challenged with
Brevundimonas diminuta in accordance with methods
specified in ASTM F838-05 (10 7 organisms / cm 2 minimum).
2 Data File 28-9257-93 AB