Cleaning, manufacturing and packaging activities in the pharmaceutical industry rely heavily on using water for various purposes. However, use of contaminated water can pose serious risks to patient safety. Strict quality standards are required for water used in pharmaceutical processes.
Classification of Water Systems
The Pharmaceutical Water classifies water systems used in manufacturing based on their intended use and risk level. The four main types are:
- Utilities water: Used in boiler feed, non-product contact cooling towers, etc. Has lowest purity standards.
- Pure steam and high purity water: Used in steam sterilizers for product/package depyrogenation/sterilization. Strict COC requirements.
- WFI water: Water for Injection. Purified water meeting pharmacopeial standards used in formulation/washing of product contact areas. Has most stringent purity criteria.
- Purified water: Used in rinsing, cleaning, etc. Purity is between utilities and WFI water.
Ensuring Purity of Water Systems
To deliver safe and pure water, the Pharmaceutical Water follows rigorous treatment and quality monitoring practices. Some key activities include:
– Source assessment and protection from contamination. Only safe sources as per WHO guidelines are used.
– Treatment trains involving filtration, ion exchange, ultraviolet irradiation, and reverse osmosis to remove particles, organisms and dissolve solids.
– Installation of distribution loops with dedicated pipework to avoid cross-contamination.
– Real time monitoring of critical quality attributes like bacteria, pyrogens and dissolved solids using online probes.
– Periodic sampling and laboratory testing as per pharmacopeial specifications. Strict action limits are set.
– Calibration and validation of all treatment and testing equipment to ensure accurate results.
– Review of water quality reports and trends analysis by quality teams on regular basis.
Ensuring integrity of Water Distribution Systems
Integrity of water distribution systems from treatment plant to point of use is critical. Key focus areas are:
– Materials of construction must be suitable for drug manufacturing and withstand cleaning and disinfection.
– Joints and connections in pipework are sealed properly to avoid leakages and contamination entry points.
– Distribution tanks, softeners and ion exchange columns are periodically stripped, cleaned and sanitized.
– Pipework is systematically checked for leakages, deposits and purged/flushed when necessary.
– Water stations are designed ergonomically for hose connections with backflow prevention.
– Automated distribution and tanker filling stations lessen manual handling risks.
Water Quality and Process Validation
For ensuring consistent quality of water, its impact on product quality is evaluated through validation protocols:
– Media fill runs check ability of water systems to deliver purified water to manufacturing areas aseptically.
– Process validation studies determine acceptable limits of process parameters and CQAs when different water qualities are used in manufacturing.
– Product characteristic tests evaluate any interaction between water impurities and drug during formulation, washing, etc.
– Lifecycle changes like additional equipment, modifications, repairs are revalidated to maintain assurance.
– Regular revalidation ensures systems and process understanding remains accurate over time.
Environmental Monitoring Program
An effective environmental monitoring program helps identify and troubleshoot any potential issues:
– Routine microbiological sampling from key locations in WFI, purified water systems and process areas.
– Viable and non-viable particle monitoring from critical filter housings and distribution loops on monthly basis.
– Endotoxins sampling from process areas involving WFI/purified water use and exotoxins when applicable.
– Trend analysis of environmental monitoring data helps proactively address rising trends before becoming OOS.
Pharmaceutical water forms the backbone of manufacturing operations. Strict quality controls and validation activities ensure process and product safety. Periodic review and improvements help maintain acceptable performance of critical water systems over their lifecycle.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
