The Pharma Compliance delivers a lab water solution focused on building the perfect relationship between discovery, production and traceability, resulting in an intuitive, efficient and compliant purification system.
- Meets the ultrapure water needs of laboratories operating under the validation conditions stipulated by GMP and good documentation practice
- Meets FDA and EU requirements for digital records CFR 11 Part 21
- Supports the TOC suitability test required by the USP 643
- Meets the line cell constant required by USP 645
- Delivers the water to support the QC tests necessary to validate drug purity in pharma manufacturing
- Consumables are designed to minimise cost and waste
- Optional additional dispenser
Purelab® Pharma Compliance is packed with innovative features optimized for QC laboratories. It offers all the necessary purification, software capabilities, qualification documentation and online support services necessary for the validation required to meet Good Manufacturing Practice (GMP).
The ultrapure water system meets your laboratories needs, with minimal intervention, improved efficiencies and a contemporary style to compliment any modern laboratory.
The Pharma Compliance includes secure software providing the evidence to meet FDA and EU standards for digital record keeping. Purification processes fulfil united states pharmacopia standards 643 and 645. Qualification documents provided enable the unit to support labs subject to validation under G×P.
Highly competitive total cost of ownership.
Robust traceability.
Great ergonomics.
A simply compliant, simply effective and simply transparent solution.
Applications: QC labs wanting to meet high level GMP regulations; QC labs with FDA CFR 21 part 11 requirements; mass spectrometry; ion, gas chromatography and HPLC; utra-trace and qualitative analysis; molecular biology; cell cultures; and electrochemistry.
Información para pedidos: For available accessories or more information, contact your Avantor representative.
