Hey, Pharma leader! I understand how challenging it can be to find reliable solutions for preserving water quality. Now that you’ve landed on this blog, rest assured—TSA has your back.
These days, the US FDA is more stringent than ever. Any product contamination can lead to warning letters, product recalls, and heavy fines for the companies involved. Beyond public health risks, such contamination incidents can seriously damage a company’s brand value and reputation.
In this blog, we’ll not only address the common challenges but also offer you practical solutions. Keep reading to learn more!
How to Preserve Water Quality In Pharma?
Big Pharma companies often struggle to prevent microbial contamination from various sources. Recently, Sun Pharma voluntarily recalled over 55,000 bottles of febuxostat tablets, a gout treatment, due to reports of microbial contamination at one of its manufacturing units. TSA understands the challenges pharma companies face, so here’s a quick guide on how to maintain water quality in the pharmaceutical industry.
1) Biofilm Formation
Biofilms usually form on the inner surfaces of pipes and storage tanks that introduce the microbes to the pure water. Also, the areas in the system with low flow or dead legs become the breeding ground due to stagnant water.
Solution: Use sanitising agents to disinfect the water system periodically to prevent biofilm formation. Implement systems designed to allow easy access for inspection and cleaning to address the biofilm issues promptly. One can rely on CIP/SIP systems to clean and sanitise the system efficiently.
2) Corrosion and Erosion
The components like pipes, valves, and tanks are made from corrodible materials like carbon steel, copper, galvanised steel, and aluminium, which can leach metals into whence compromising purity. As the water is introduced into the system at high velocity, it may cause erosion of its components, thereby introducing particles and contaminants into the water.
Solution: Choose equipment and systems produced from stainless steel only. TSA offers a Water-for-injection system that delivers water that meets the most stringent standards in the world. We have designed our uniquely efficient purification system in SS 316L, and all the contact parts are electropolished to less than 0.4 RA microns, and the joints are orbitally welded. It is a pre-passivated system offering high flexibility with a variable production capacity of up to 80% without additional plant modification.
TSA’s Water for Injection System
3) Temperature Fluctuations
In the pharmaceutical industry, various operations occur at different temperatures. Elevated temperatures cause materials to expand, followed by contraction. This temperature change can create microscopic cracks or crevices in pipes or equipment surfaces. Such crevices allow microbial growth, making it challenging to sanitise them using regular cleaning methods and cycles. These crevices harbour microbes, leading to pure water contamination.
Solution: Select equipment/systems with smooth and seamless design to eliminate crevices and minimise the chance of microbial growth. Additionally, invest in equipment that innovative technology, such as IoT, integrated into them. The IoT devices help in the real-time assessment of temperature and humidity, allowing predictive maintenance.
Also, routine checks are advised for signs of wear and tear, especially in areas subject to temperature fluctuations. You can also choose non-destructive testing methods like ultrasonic or dye penetrant testing to identify any microscopic damage to the system.
The areas prone to temperature fluctuations must be cleaned more frequently to prevent microbial buildup. Besides this, the storage tanks and distribution systems must be strictly maintained in temperature-controlled environments, as warmer temperatures support microbial growth. The storage areas must have good ventilation systems to minimise risks of airborne contamination.
4) Poor Maintenance and Cleaning Practices
Without routine sanitisation of the water purification system, the biofilm can form on the filters or RO membranes, thus affecting the water quality. Also, incomplete rinsing after chemical cleaning can leave traces of these chemicals and degrade the water quality.
Solution: You can create a detailed plan to schedule cleaning and sanitising the system. Ensure the plan details the frequency at which every component, like tank, pipe and distribution system, must be cleaned.
You must ensure that validated cleaning protocols are followed for effective sanitisation. This includes the use of correct cleaning agents and methods.
The team must follow Clear guidelines for replacing components based on manufacturer recommendations and operational conditions.
We advise you to implement testing methods to test any residual cleaning agents to guarantee that the rinse water meets quality standards before the system is put back into operation.
All the maintenance activities must be well-documented. You can use digital tools to streamline record-keeping for easy audits. You can also call external experts to audit water purification systems periodically. These experts not only provide you with an objective assessment but also recommend best practices for maintaining and cleaning.
5) Environmental Contaminants
Dust, pollen and other airborne contaminants can degrade the water quality. These pollutants enter the system when the system is not well concealed.
Also, seasonal variations are responsible for changes in source water quality, such as high TOC. These variations in source water, in turn, affect the purification efficiency and the final water quality.
Depending on the local treatment practices, the source water can contain high chlorine levels, minerals, and other impurities.
Solution: To prevent airborne contamination, prefer using closed-loop systems for purified water. These closed-loop systems must be routinely checked for integrity.
To overcome the challenge of seasonal variations and local treatment practices, systems with RO membranes, deionisation, and ultrafiltration for water purification are preferred.
Source: Freepik
6) Inadequate Monitoring and Control Systems
Lack of continuous monitoring lets go of minor chemical imbalances and undetected microbial contaminants. This can further become a significant problem. Also, the sensors for critical parameters like pH, conductivity, and TOC are not regularly calibrated. Therefore, the data produced is not reliable.
Solution: As it gets difficult to manually monitor critical parameters continuously, invest in automated monitoring systems to get real-time data for pH, Conductivity, temperature, and TOC. You can also use self-diagnosing sensors, which are smart enough to send alerts when calibration or maintenance is required.
Besides intelligent monitoring systems, manual spot checks are advised to verify the accuracy of these systems. Additionally, you can rely on predictive maintenance tools to analyse the sensor data trends over time. This tool helps predict potential system failures or parameter fluctuations before they become serious issues. You can also use Quality Management Systems (QMS) to maintain traceable records. A QMS helps comply with regulatory requirements and efficiently identifies the root of an issue.
At TSA, we design biopharma vessels following the QRM/QRS approach, adhering to ASME/BPE/PED guidelines, with capacities ranging from 5L to 50KL. Our vessels are fully customisable, including options such as jacketed or insulated, mobile skid or fixed in place, CIP/SIP integrated, top or bottom mounted mixing, seal or magnetic, automatic, semiautomatic, or manual, level sensing, load cell, DPT or radar.
Source: TSA’s Vessels for BioPharma.
7) Inadequate Staff Training
When the staff is adequately trained, the personnel may inadvertently contaminate the water system. The personnel may also overlook the early signs of water quality issues.
Solution: Training the new joiners is crucial before they handle the critical purification systems. As the regulations are updated promptly, training must be provided regularly to inform the employees of those changes.
Before tackling complicated equipment, it is essential to provide hands-on training sessions to the personnel so that they can observe and practice proper techniques under supervision. This not only ensures the retention of information but also confirms the procedures are followed accurately.
The leaders must regularly evaluate the staff’s performance and understanding of the water system’s procedure. A leader is responsible for encouraging the employees to report challenges or suggest improvements to foster a continuous learning environment.
Conclusion
Although our discussion on preserving water quality ends here, we’re eager to continue the conversation with you. Let us know your challenges—our team of multidisciplinary experts is ready to craft tailored solutions to address them. Every challenge is welcome! TSA is your reliable and approachable partner. Contact us today!
Frequently Asked Questions (FAQs)
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What impact does climate change have on water quality?
Climate change affects water quality in several significant ways. Rising temperatures can increase evaporation rates, leading to higher concentrations of pollutants in water bodies. Warmer waters also facilitate the growth of harmful algal blooms and bacteria, which can contaminate drinking water sources. Additionally, increased frequency and severity of storms can lead to more runoff, introducing sediments, nutrients, and other pollutants into waterways. Sea level rise may cause saltwater intrusion in coastal freshwater sources, compromising water quality and availability for drinking and agriculture.
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Why is pH balance important for water quality?
pH balance is crucial for water quality because it influences the solubility and biological availability of chemical constituents such as nutrients and heavy metals. Water with a pH that is too low (acidic) or too high (alkaline) can corrode pipes and dissolve toxic metals, leading to potential health risks.
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What are the best practices for maintaining water quality?
To maintain high water quality, the water must be regularly tested for microbial, chemical, and physical contaminants. Ensure no biofilm is formed, and implement proper cleaning and sanitization methods. Invest in intelligent sensors to detect any anomalies in the critical parameters and report timely alerts to take preventive measures. Purification systems manufactured with SS 316L prevent any defect in the material that supports microbial growth.
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What role do water filtration systems play in preserving water quality?
Water filtration systems are essential for removing contaminants and ensuring water quality. They help eliminate particles, sediments, bacteria, and other pollutants that can compromise health and safety. Using filtration systems designed by TSA removes contaminants such as chlorine, heavy metals, and harmful microorganisms, providing cleaner, safer water. Opt for advanced systems, like reverse osmosis and UV filtration, to address more specific issues, such as chemical contaminants and pathogens, playing a crucial role in immediate water quality improvement. Contact TSA to know more.
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How can I detect signs of water contamination in my drinking water?
Some signs of water contamination are visible, while others require testing. The early signs of contamination include cloudy, murky or discolored water, a strong smell of chloride, rotten egg, or any unusual odor. A metallic or bitter taste suggests the presence of harmful chemicals or minerals. The presence of sediment in water indicates pipe corrosion.
