Running a successful pharmaceutical manufacturing operation requires very careful planning and execution of different individual processes. It involves steps from blending, wet granulation, drying, coating to the ultimate test of quality control. One of the most important processes of any pharmaceutical manufacturing unit is the purified water process. Like all other manufacturing processes, water is a very major component of pharmaceutical production too. It is widely used as raw material, ingredient and solvent in the processing, formulation, and manufacture of pharmaceutical products. It is also used as a cleaning agent for rinsing vessels, equipment, and primary packing materials, etc. Therefore, it is crucial that the water systems are designed and installed with a focus on purity. However, the health of a water system involves a lot more than just design and installation. One needs to take carefully planned steps to keep the system running smoothly. Producing and maintaining high purity water is not simply a matter of legal compliance, it also carries with it consumer confidence especially in Pharmaceutical Industries.
We have blogged extensively about different water treatment methods and guidelines for keeping your water systems healthy. Here is a list of 5 mistakes we have seen made time and again that impact the working of the entire manufacturing process. Let’s dive right in:
1. Ignore testing and monitoring – Perhaps the most important tip any vendor can give you is to continuously monitor your water systems. A pure water system is an amalgamation of different machines and tools. These machines go through normal wear and tear during the process of production. Conducting routine testing and monitoring by a trained technician ensures that the water produced is in the acceptable range.
2. Skip periodic maintenance – The next step after monitoring is taking corrective action. Although water systems are designed with the utmost care, they require constant maintenance to preserve the purity of the product. Any discrepancies reported during routine monitoring need to be reported and measures need to be taken to calibrate the system with the initial quality documents of the unit.
3. Expanding water usage without system review – A growing business will increasingly need more and more resources. If your pharmaceutical manufacturing business is thriving, it will require additional pure water to fulfill its booming production. While expanding the capacity is good for the business, you need to make sure that the water systems are already in good health. Therefore expanding capacity without a thorough system review is a mistake that producers tend to make. This affects their ability to meet standards and ultimate4ly impacts the bottom line.
4. Overlook filter and membrane health – A company is only as good as the people working in it. Like a company, a water system ‘employs’ various filters and membranes to purify water for manufacturing pharmaceutical products. Therefore, it is essential to the overall working of any water system that its filters and membranes are in good shape. You need to make sure to evaluate the health of filters, membranes, and other internal mechanisms and assess their reliability. If determined, that they have run their course and are not fit for further use, they need to be replaced so as not to affect the purity of the water produced in the system.
5. Employ a vendor without FDA protocol – All the design, installation and maintenance planning may go down the drain if your vendor does not follow a proper FDA protocol. An FDA protocol drives the need for quality system requirement procedures and practices. Make sure that your vendor has an FDA protocol in place before initiating monitoring and maintenance activities.
With the above, we have tried highlighting the most typical errors encountered in pure water systems. All pharmaceutical products’ quality needs to comply with standards set by national and international agencies. This makes the role of a pure water unit all the more important and leaves very little margin for error. TSA water system is a leader in the manufacture and installation of high purity water systems. With in-depth knowledge and detailed know-how of how water purity works, we aim to transform the industry and set new standards for pure water. We are the preferred partners for pharmaceutical water systems.