As you know, water plays a pivotal role in pharmaceutical manufacturing, where it is used as a raw material, solvent, cleaning agent, and an integral ingredient in drug production.
A Purified water system ensures you comply with regulatory standards and deliver high-quality pharmaceutical products. However, there are common errors in water system management that can disrupt operations, compromise product quality, and lead to non-compliance.
At TSA, we’ve identified the top mistakes that companies make with high-purity water systems. Here’s how to avoid them:
1. Neglecting Testing and Monitoring
Regular testing and monitoring are non-negotiable for maintaining water quality and system efficiency. Without it, contaminants may go undetected, jeopardizing product safety and regulatory compliance.
Pro Tip: Implement a routine monitoring protocol and engage trained technicians to promptly identify and address any issues.
2. Skipping Preventive Maintenance
Even the best water systems need periodic maintenance to prevent performance degradation. Delaying this can lead to costly breakdowns or inefficiencies.
Pro Tip: Schedule consistent maintenance to ensure your system operates as per design specifications and compliance standards.
3. Scaling Without Reviewing System Capacity
With an increase in production demands, water usage increases. If you expand your operations without evaluating the system’s capacity, it can lead to inefficiencies and quality lapses.
Pro Tip: Conduct a thorough review of your water system before scaling operations to ensure it meets increased demands.
4. Overlooking Filter and Membrane Health
Filters and membranes are the workhorses of any purification system. Failure to inspect and replace these components on time can compromise water quality.
Pro Tip: Develop a proactive replacement schedule for filters and membranes to maintain system integrity and water purity.
5. Choosing Unqualified Vendors
Not all vendors adhere to FDA protocols or offer systems designed for compliance and efficiency. Partnering with a non-compliant vendor can put your operations at risk.
Pro Tip: Always work with vendors who follow FDA guidelines and have proven expertise in pharmaceutical-grade water systems. TSA has worked relentlessly for over a decade, serving premium quality water purification systems to the Pharma, Biopharma and Biotech Industries—partner with us for advanced and reliable water solutions.
Why Proper Management Matters
High-purity water systems are the backbone of pharmaceutical manufacturing, ensuring product safety, regulatory compliance, and consumer trust. Neglecting any aspect of their maintenance or operation can lead to costly recalls, production downtime, and reputational damage.
Why Choose TSA?
At TSA, we provide the most advanced, high-purity water systems designed to meet your unique needs. With a focus on compliance, efficiency, and sustainability, we deliver systems that exceed industry standards.
Our water treatment solutions are available in various models with flow rates ranging from 200 LPH to 20,000 LPH, with water and energy efficiencies through recycling. The system uses heat sanitisation and incorporates softening, reverse osmosis and continuous electro-ionisation to generate highly pure water that meets your needs. All the systems are skid mounted and comply with US FDA 21 CFR Part 11 and GAMP 5. We also provide operational and maintenance contracts and plant spares for frictionless operations.
Ready to elevate your pharmaceutical water processes?
Contact TSA today for innovative solutions tailored to your operations.
FAQs
1) What parameters should be monitored?
Depending on the application, key parameters include conductivity, total organic carbon (TOC), microbial levels, and endotoxin levels.
2) How frequently should water quality be tested?
Regular testing is crucial, with frequency depending on industry requirements. For pharmaceuticals, daily or batch-specific testing may be necessary.
3) What are the most common mistakes made in managing high-purity water systems?
Common mistakes include poor maintenance, improper cleaning, neglecting regular testing, using incompatible materials, and failing to train staff adequately.
