FDA ALCOA Guidance
FDA ALCOA Guidance Maintaining Data Integrity: Understanding FDA ALCOA Guidance Did you know that…
Pharmaceutical Water Quality
Water is one of the major commodities used by the pharmaceutical industry. It may be present as an excipient or used for reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent for rinsing vessels, equipment, primary packaging materials etc. by Cleaning In Place (CIP) methods.
Pharmacopoeia Requirements for WFI
Different grades of water quality are required depending on the different pharmaceutical uses. Control of the quality of water, in particular the microbiological quality, is a major concern and the pharmaceutical industry devotes considerable resource to the development and maintenance of water purification systems. The European Pharmacopoeia (Ph. Eur.) provides quality standards for grades of water for pharmaceutical use including Water for Injection (WFI), Purified Water and Water for preparation of extracts. The following parameters must be controlled in WFI.
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TOC < 500 ppb
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Conductivity < 1.1 µS/cm at 20°C
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Nitrates < 0.2 ppm
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Heavy Metals < 0.1 ppm
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Aerobic Bacteria < 10 CFU/ 100ml
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Endotoxines 0.25 I.U./ml
Production of WFI, change of method
Until April 2017 the production of Water For Injection (WFI) had been limited to distillation only. Following extensive consultation with stakeholders, the Ph. Eur. monograph for Water for Injections (0169) was revised in order to allow the production of WFI by a purification process “equivalent to distillation”, such as reverse osmosis coupled with appropriate techniques such as electrodeionization, ultrafiltration or nanofiltration. The production of WFI by means of these methods is often referred to as COLD WFI.
The production costs per liter for cold WFI are much lower because of the much lower capital investment in equipment for membrane based systems against thermal production equipment. At the same time large energy savings will be achieved which makes this method more environmental friendly. Notice is given to the supervisory authority of the manufacturer before implementation of any method of production. However, due to the moderate temperatures in the production of COLD WFI compared to the method of distillation the formation of biofilms is more likely in the production of COLD WFI.
The new draft of the GMP Annex 1 requires continuous monitoring systems for TOC and Conductivity as these may give a better indication of the overall performance than discrete sampling. The sensor locations should be based on a risk assessment and the outcome of the qualification. Whether you are looking for an online TOC analyzer or a laboratory analyzer with autosampler for a high throughput of samples per day we have the solution with the Anatel TOC analyzers.
The Anatel PAT700 was specifically designed for online monitoring of Purified Water (PW) and Water For Injection (WFI) with a low detection limit and high accuracy within the GMP regulated pharma and biopharma industries. The Anatel Qbd1200 was designed for analysis of grab samples in the laboratory and has an uncerpassed accuracy and throughput with the optional autosampler.
PAT700 Online TOC and Conductivity Monitoring
The Anatel PAT700 Total Organic Carbon (TOC) Analyzer is specifically designed to help demonstrate compliance to the pharmacopoeial requirements for TOC and conductivity for Purified Water (PW) and Water For Injection (WFI). It can be used for Real-Time-Release, “defined as” the ability to evaluate an ensure the acceptable quality of in process and/or final product based on process data. Real-Time-Release-Testing ensures faster and saver batch release while at the same time realizing savings because expensive laboratory analyses of grab samples can be limited or completely unneccasary.
Monitoring of Pharmaceutical Water
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On-line monitoring of Purified Water
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Laboratory TOC analysis
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Real-Time-Release Testing
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Low Total cost of ownership
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Full Compliance with all Pharmacopoeias
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21 CFR part 11 Compliance
Qbd1200 Laboratory TOC analyzer
The new QbD1200 TOC analyzer is designed to make testing easier, reproducible and accurate. The new TOC analyzer promises highest performance while dramatically reducing cost of ownership by using one reagent for the test and requiring only one annual service call rather than frequent maintenance. The new TOC analyzer eliminates the dependency on lengthy overnight routines that may fail. In the first of its kind the QbD1200 TOC analyzer calibrates in only 90 minutes. The QbD1200 is designed for use in 21 CFR part 11 lab environments and is fully compliant with all global pharmacopeia regulations. It offers convenient validation as it is not operated by a separate PC eliminating the need for an additional CSV file and provides paperless reporting to distribute all auditable reports over secure protocol to a central server.
