Pharmaceutical Water System Validation

Documented evidence for Pharmaceutical Water Systems 

Documented evidence for Pharmaceutical Water Systems 
Overview

We understand Pharmaceutical water system validation, we understand the challenges and how to successfully handover compliant water treatment systems to our customers. We’ve been validating water systems for over twenty years. Using this experience we’ve developed a comprehensive process to support the validation of small lab water systems through to large bespoke Pharmaceutical water systems. This process is embedded in our own ISO9001 quality procedures.

 

Orion

 

Expertise in delivering compliant water treatment systems

Our People

Our validation experts have years of experience in designing, qualifying and validating pharmaceutical water systems. Our specialist team of designers, project managers, installers, commissioning engineers and validation engineers are purely focused on the Pharmaceutical market and have built up their expertise through firsthand experience.

 

Pharmaceutical Water System Design

 

All our Pharmaceutical water systems including the Orion, Polaris range, IonPro and distribution systems are designed in line with industry guidelines such as GAMP, US Pharmacopia, Eur Pharmacopia.

During the design of a system our team follow the necessary guidelines to ensure that the design meets all of the applicable Pharmaceutical water treatment system requirements.

 

Qualification process

 

We have used our experience to develop a range of standard validation documents for all of our Pharmaceutical water treatment systems including – design qualifications, factory acceptance tests (FAT), installation qualification (IQ) , commissioning and operation qualification (OQ) all supporting drawings, certification, schedules, certification, etc.  

However, we have the flexibility to supply bespoke and hybrid qualification documentation based on customer requirement.

Ongoing performance qualification

 

We handover the Pharmaceutical water system post Operational qualification testing. However, we do offer ongoing validation support services if further support to complete performance qualification (PQ) is required.

 

ORIONcare and PQMC

Developed in conjunction with and used by major pharmaceutical companies to demonstrate compliance in the way they operate and maintain their high purity water treatment systems.

  • ORIONcare has been specifically designed for our range of validated Orion high purity water treatment plants.
  • PQMC (Performance Qualification Maintenance Contract) has been designed to cover other validated high purity water treatment plants supplied by Veolia

ORIONcare and PQMC Contracts are designed to demonstrate that the water system is producing water to the required specification (typically carried out 4 times per year).  They set out a series of performance measures that are specific to each item of equipment that makes up the water system shown in detail on the Process and Instrumentation Diagram.  Full performance tests are carried out and recorded for each item of equipment.  All results are fully documented and tests carried out to published protocols and standards. The compilation of the data, with any conclusions and recommended actions to ensure continued compliance is added into the final report for review and countersignature with the customer.

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