Integrity tester WRTP-1000 for RTP
Integrity tester WRTP-1000 for RTP
Description :
Medintegrity Aseptic lsolator Technology Solutions
Evaluating new aseptic handling/transfer technology
During sterle drug manufacure and formulafion,one of the most challenging aspects of manufacture is
the point at which ingredientsneed to be transferred into and out of a particular process while ensuring the integrity of the product and the critical area.
Evaluating new aseptic handling/transfer technology
During sterle drug manufacure and formulafion,one of the most challenging aspects of manufacture is
the point at which ingredientsneed to be transferred into and out of a particular process while ensuring the integrity of the product and the critical area.
- Compliance wih FDA21CFR part 11,EUAnnexl,and GAMP5
- The user interface is friendly and allows the user an easy handing of the RTP integriy tesing
- Medintegrity RTP test system can be integrated into other equipment, as well as into different type of ports:oval or circular with different diameters
- Based on a well-established alphal/beta concept to allow for reliable and secured sterile transfer while maintaining the integrity of the critical area/isolators,RABS ,and clean rooms.
Integrity tester WRTP-1000 for RTP
Application :
Alpha Port: Transfer solutions from lower classified enviroments to higher classification process zones.
Beta Port:Transfer solutions from lower classified enviroments to higher classification process zones.
Installation Requiremnts : Alpha Port : N/A
Beta port : Wall thickness 3-8mm If the wall thickness exceeds 8mm the accessories support is necessary
Parameters
Weight(approx.) | 4kg+βport | 4KG+αport |
Operating Temp Ronge | 5℃~30℃ | 5℃~30℃ |
Pressure Range | Posiive Pressure:30kPa Negafive Pressure:-30kPa | PositivePressure:30kPa
Negative Pressure:-30kPa |
Materials of
Construction |
StainlessSteel 316L/PETP/ Silicone/EPDM/PTFE | Slainless Steel 316L/PETP/ Silicone/EPDMPTFE |
Available Diameter | 190mm 270mm
Customized |
190mm 270mm
Customized |
Quality Standards | GMP/cGMP | GMP/CGMP |
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