Water is an essential ingredient to pharmaceutical manufacturing. Once purified, non-compendial water, purified water or water for injection must be stored and distributed in systems appropriately designed, installed, commissioned and validated. Controlling the water quality in the distribution loop to ensure delivery to the point of use at the required flow and temperature can be challenging. Which is why pharmaceutical manufacturers looking for sustainable, energy-efficient solutions to deal with, or prevent, rouging, biofilm buildup or other impurities in the water distribution loop look to Alfa Laval as a trustworthy partner.
To make easy work of system and equipment validation, there’s Alfa Laval Q-doc, our cutting-edge documentation package for the pharmaceutical industry. For hassle-free qualification and validation, Q-doc encompasses every aspect of production, from raw material sourcing to the delivery of finished equipment. This provides full transparency and enables the slightest change in material or manufacture to be traced – even when it comes to spare parts.
Objective of pharmaceutical water systems
- Maintain water quality within acceptable limits
- Deliver water to the points-of-use at the required flow and temperature
- Minimize capital investment and operating expenses
- Ease validation of all equipment, spare parts and service kits
Rely on Alfa Laval as your single supplier to help you meet to the stringent demands of pharmaceutical water systems. It’s easy to comply with all the pharmaceutical requirements for safety, hygiene, economy, energy-efficiency and reduced waste simply by taking advantage of our vast pharmaceutical process expertise, broad and proven hygenic equipment and global service network
Pharmaceutical water system
Why choose Alfa Laval
- Energy savings from pumps, diaphragm valves and Pharma-X heat exchangers
- Easy installation, validation and maintenance with Alfa Laval Q-doc
- Minimized sanitization time due to improved bacteria control from hygienically designed and crevice-free Alfa Laval equipment
- Minimized rouging thanks to Alfa Laval’s UltraPure surface finish with controlled and optimized polishing and cleaning procedures
- Minimized maintenance due to an optimized Alfa Laval water-for injection (WFI) pump shaft seal, long-lasting diaphragms and high-quality shell-and-tube heat exchanger
Challenges to maintain the right quality of pharmaceutical water
Do you recognize any of these challenges?
Improperly designed, operated and maintained pharmaceutical water systems can be much more expensive than investing in the right pharmaceutical water systems from the start. This is why it is important to consider these challenges when selecting pharmaceutical water system equipment.
Rouge. Rouge involves the precipitation and spread of fine red-brown ferric oxide or hydroxide particles from the place of origin to associated systems. It can often be found in circulation pumps, diaphragm valves and inside tanks equipped with static spray balls. While rouge cannot be avoided, it is possible to minimize the level of rouging by choosing the right hygienic equipment using the right design and high-grade 316L steel as well as ensuring proper system installation, operation and maintenance.
Biofilm buildup. Populations of live microorganisms as well as dead microbial cells can form a layer, or biofilm, on the surfaces of pharmaceutical water system equipment. This film also contains noncellular materials, such as mineral crystals, corrosion particles or silt particles. In fact, more than 99% of all microbial activity occurs in biofilm. Biofilm buildup poses contamination risks to pharmaceutical water systems. However, proper equipment and system design can reduce these risks.
Energy consumption and carbon emissions. Maintaining continuous circulation and high temperatures in hot water systems is expensive and energy-intensive. It also adversely impacts the environment due to carbon emissions. There are, however, ways to reduce energy consumption without compromising quality or performance.
Safe and easy installation, validation and maintenance. Ensuring proper installation, validation and maintenance of water systems is a business imperative for the pharmaceutical industry. After correct installation and validation, it is critical that genuine wear parts are replaced with a part that matches the exact material and characteristics of the original part in order to prevent the need for costly revalidation. To help maximize uptime, thorough and uniform equipment documentation helps secure proper installation, validation and maintenance using the correct parts, all of which leads to more uptime.
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