Single Use Assembly Technical Data
PROCLEAR PP Filters
MATERIALS OF CONSTRUCTION
- Filtration Media, Upstream Support & Downstream Support: Polypropylene
FILTER CARTRIDGES
- Inner Support Core, Outer Protection Cage & End Caps: Polypropylene
- End Caps Insert: 316L Stainless Steel
MURUS DISPOSABLE FILTER CAPSULES
- Core, Sleeve & Capsule Body: Polypropylene
- End Caps Insert: 316L Stainless Steel
- Standard O-Rings/Gaskets & Capsule Vent Seals: Silicone
DEMICAP FILTER CAPSULES
- Core, Sleeve & Capsule Body: Polypropylene
- Capsules Vent Seals: Silicone
- Filling Bell: Polycarbonate
SYRINGE FILTERS
RECOMMENDED OPERATING CONDITIONS
FILTER CARTRIDGES
Up to 70 °C (158 °F) continuous operating temperature and higher short-term temperatures during CIP to the following limits:
| Temperature |
Max. Forward dP |
| °C |
°F |
(BAR) |
(PSI) |
| 20 |
68 |
5.0 |
72.5 |
| 40 |
104 |
4.0 |
58.0 |
| 60 |
140 |
3.0 |
43.5 |
| 80 |
176 |
2.0 |
29.0 |
| 90 |
194 |
1.5 |
21.7 |
MURUS DISPOSABLE FILTER CAPSULES
- Up to 25 °C ( 77 °F) @ 5.5 barg (79.7 psig)
- Up to 60 °C (140 °F) @ 2.8 barg (40.6 psig)
DEMICAP FILTER CAPSULES
- Up to 40 °C (104 °F) at line pressures up to 5.0 barg (72 psig)
EFFECTIVE FILTRATION AREA (EFA)
- 10¨ (250 mm) up to 0.79m2 (8.5 ft2)
STERILISATION
- PROCLEAR PP filter cartridges can be sanitised with hot water at up to 90 °C (194 °F) and are compatible with a wide range of chemicals
| Autoclave |
Steam-in-Place |
|
Cycles |
Temp |
Cycles (30 min.) |
Temp |
| Cartridges |
10 |
130°C (266°F) |
30 |
135°C (275°F) |
| MURUS |
5 |
130°C (266°F) |
– |
– |
| DEMICAP |
10 |
130°C (266°F) |
– |
– |
| Syringe |
1 |
130°C (266°F) |
– |
– |
BIOLOGICAL SAFETY
- Materials conform to the relevant requirements of 21 CFR Part 177 and current USP Plastics Class VI – 121 °C and ISO10993 equivalents
QUALITY STANDARDS
- Pharmaceutical grade products are manufactured in accordance with cGMP, 100% flushed with pharmaceutical-grade purified water
GAMMA-IRRADIATION
- PROCLEAR PP MURUS & DEMICAP disposable filters can be gamma-irradiated up to a maximum dosage of 40 kGy
PROCLEAR PP+ Filters
MATERIALS OF CONSTRUCTION
- Filtration Media, Upstream Support & Downstream Support: Polypropylene
FILTRATION CARTRIDGES
- Inner Support Core, Outer Protection Cage & End Caps: Polypropylene
- End Caps Insert: 316L Stainless Steel
MURUS DISPOSABLE FILTER CAPSULES
- Core, Sleeve & Capsule Body: Polypropylene
- End Caps Insert: 316L Stainless Steel
- Standard O-Rings/Gaskets & Capsules Vent Seals: Silicone
RECOMMENDED OPERATING CONDITIONS
FILTER CARTRIDGES
- Up to 70 °C (158 °F) continuous operating temperature and higher short-term temperatures during CIP to the following limits:
| Temperature |
Max. Foward dP |
| °C |
°F |
(BAR) |
(PSI) |
| 20 |
68 |
5.0 |
72.5 |
| 40 |
104 |
4.0 |
58.0 |
| 60 |
140 |
3.0 |
43.5 |
| 80 |
176 |
2.0 |
29.0 |
| 90 |
194 |
1.5 |
21.7 |
MURUS DISPOSABLE FILTER CAPSULES
- Up to 25 °C ( 77 °F) @ 5.5 barg (79.7 psig)
- Up to 60 °C (140 °F) @ 2.8 barg (40.6 psig)
EFFECTIVE FILTRATION AREA (EFA)
- 0¨ (250 mm): 0.5 m2 (5.4 ft2)
STERILISATION
PROCLEAR PP+ filter cartridges can be sanitised with hot water at up to 90 °C (194 °F) and are compatible with a wide range of chemicals.
|
Autoclave |
Steam-in-Place |
|
Cycles |
Temp |
Cycles (30 min.) |
Temp |
| Cartridges |
10 |
130°C (266°F) |
30 |
135°C (275°F) |
| MURUS |
5 |
130°C (266°F) |
– |
– |
BIOLOGICAL SAFETY
Materials conform to the relevant requirements of 21CFR Part 177 and current USP Plastics Class VI – 121 °C and ISO10993 equivalents
QUALITY STANDARDS
Pharmaceutical grade products are manufactured per cGMP, 100% flushed with pharmaceutical grade purified water.
GAMMA-IRRADIATION
PROCLEAR PP+ MURUS
Disposable filters can be gamma-irradiated up to a maximum dosage of 40 kGy.
PROCLEAR GF FILTERS
MATERIALS OF CONSTRUCTION
- Filtration Media: Glass Microfibre
- Upstream & Downstream Support: Polypropylene
FILTER CARTRIDGES
- Inner Support Core, Outer Protection Cage & End Caps: Polypropylene
- End Caps Insert: 316L Stainless Steel
RECOMMENDED OPERATING CONDITIONS
FILTER CARTRIDGES
- Up to 70°C (158°F) continuous operating temperature and higher short-term temperatures during CIP to the following limits:
| Temperature |
Max. Forward dp |
| °C |
°F |
(BAR) |
(PSI) |
| 20 |
68 |
5.0 |
72.5 |
| 40 |
104 |
4.0 |
58.0 |
| 60 |
140 |
3.0 |
43.5 |
| 80 |
176 |
2.0 |
29.0 |
| 90 |
194 |
1.5 |
21.7 |
MURUS DISPOSABLE FILTER CAPSULES
- Up to 25°C ( 77°F) @ 5.5 barg (79.7 psig)
- Up to 60°C (140°F) @ 2.8 barg (40.6 psig)
DEMICAP FILTER CAPSULES
- Up to 40 °C (104 °F) at line pressures up to 5.0 barg (72 psig)
EFFECTIVE FILTRATION AREA (EFA)
| 10″ (250mm) |
0.56 m² (6.0 ft²) |
| K Size |
0.27 m² (2.9 ft²) |
| A Size |
0.20 m² (2.2 ft²) |
| B Size |
0.10 m² (1.1 ft²) |
| E Size |
0.05 m² (0.6 ft²) |
| Syringe ø50 mm |
14.50 cm² (2.25 in²) |
STERILISATION
|
Autoclave |
Steam-in-Place |
|
Cycles |
Temp |
Cycles (30 min.) |
Temp |
| Cartridges |
10 |
130°C (266°F) |
10 |
121°C (249.8°F) |
| MURUS |
5 |
130°C (266°F) |
– |
– |
| DEMICAP |
10 |
130°C (266°F) |
– |
– |
| Syringe |
1 |
130°C (266°F) |
– |
– |
- PROCLEAR GF filter cartridges can be sanitised with hot water at up to 90 °C (194 °F) and are compatible with a wide range of chemicals.
BIOLOGICAL SAFETY
- Materials conform to the relevant requirements of 21CFR Part 177 and current USP Plastics Class VI – 121 °C and ISO10993 equivalents.
QUALITY STANDARDS
- Pharmaceutical-grade products are manufactured per cGMP, 100% flushed with pharmaceutical-grade purified water.
GAMMA-IRRADIATION
- PROCLEAR GF MURUS & DEMICAP disposable filters can be gamma-irradiated up to a maximum dosage of 40 kGy.
