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Beijing Niuyin Huaxin Technology Development Co., Ltd
RTP detector
NegotiableUpdate on 01/30
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Overview
RTP detector: One of the challenging aspects in the manufacturing and formulation process of sterile drugs is the need to transfer ingredients to a specific process while ensuring the integrity of the product and critical areas.
Product Details
RTP detector
One of the challenging aspects in the manufacturing and formulation process of sterile drugs is the need to transfer ingredients to a specific process while ensuring the integrity of the product and critical areas.
Regarding aseptic manufacturing, the current good manufacturing guidelines of the World Health Organization (WHO) and other regional regulatory agencies include industry guidelines for sterile drugs produced through aseptic processing, which require minimizing the number of transfers to cleanrooms or isolators. The guide also states that products should be transferred under appropriate clean room conditions, using appropriately designed transfer equipment and transfer systems.
The advanced RTP integrity detection system of Niuyin Technology effectively ensures the integrity of the height classification area of the RTP valve itself, ensuring that the product contact surface is in a sterile state. The application of Niuyin Technology's advanced RTP integrity detection system will effectively reduce the risk of contamination during sterile transmission.
RTP Integrity TesterProduct Specifications
| Alpha valve/Alpha Port | Beta valve/Beta Port | |
Application scenarios |
Fast transfer solution in controlled classification environment |
Fast transfer solution in controlled classification environment |
| Installation requirements | N/A |
Wall thickness: 3-8mm *If the on-site wall exceeds 8mm, auxiliary accessory brackets are required. |
| weight | 4KG+Bplate | 4KG+alpha disk |
| Operating temperature | 5°C~30°C | 5°C~30°C |
| pressure range |
Positive pressure: 30kPa Negative pressure: -30kPa |
Positive pressure: 30kPa Negative pressure: -30kPa |
| material | 316L/PETP/resin/EPDM/PTFE | 316L/PETP/resin/EPDM/PTFE |
| valve size |
190mm 270mm 定制 |
190mm 270mm 定制 |
| quality standard | GMP/CGMP | GMP/CGMP |
RTP detectorProduct advantages
Automated testing; User friendly operation; Reliable data
●Compliant with FDA 21 CFR Part 11C, EU Annex 11, and GAMP 5
●High sensitivity, advanced pressure control, and fast detection.
●User interface friendly, allowing users to easily perform RTP integrity testing.
●The device is compact in size, easy to move, portable, and quickly connected.
●Guarantee of RTP integrity.
●The RTP integrity testing of Nuoyin Technology can be integrated into other devices and different types of ports, and is widely used in RTP systems of different design sizes.
●The RTP integrity testing equipment of Nuoyin Technology is based on a comprehensive isolation application concept, ensuring the reliability and safety of sterile transmission and critical area isolators, RABS, and cleanrooms.
Application of sterile rapid transfer interface detection standards
●Applied to transfer sterile rubber plugs, bottle caps, etc. to isolator/RABS production lines
●Applied to transfer disposable filling tubes to isolator/RABS production lines
●Applied to liquid transfer (transfer between isolators/RABS or production spaces)
●Applied to environmental monitoring equipment entering the isolator/RABS production line
●Applied to tools entering the isolator/RABS production line
●Applied to controlled environment entry and exit
●Applied to isolator/RABS for transferring waste materials
