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Integrity tester WRTP-1000 for RTP

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.
  • 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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