Bringing a drug or a vaccine to market requires cutting-edge technologies. To succeed, pharmaceutical manufacturers demand efficient, hygienic equipment that delivers continuous processes and sustainable performance – scalable from pilot to full-scale production.
Distributing pharmaceutical water – continuously,economically and sustainably
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
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.
Pharmaceutical water systems
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. Choose an Alfa Laval hygienic equipment below in the process chart for full information on our solutions for pharmaceutical water systems.
Producing complex protein-based drugs is an important and fast-growing sector for the biopharmaceutical industry. Manufacturing viral vaccines, monoclonal antibodies, glycoproteins, therapeutics and other drugs requires purpose-built systems for gentle but efficient fermentation, harvesting and purification. Successful production requires hygienic equipment that handles cells gently, eliminates the risk of contamination and maximizes yield.
Alfa Laval Q-doc documentation package
Alfa Laval Q-doc is our comprehensive documentation package for our UltraPure equipment. Based on Good Documentation Practice (GDP), Q-doc documents every aspect from raw material to delivered equipment. With full transparency of sourcing, production and supply chains it is a simple matter to trace even the slightest change in material or manufacturing procedures – even when it comes to spare parts.
Equipment serial number or lot number for service kit
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Documentation for biotech and pharmaceutical needs
The standard Alfa Laval Q-doc documentation package for Alfa Laval UltraPure equipment ensures full traceability of all product contact parts such as, steel, gaskets, etc. This secures a perfect match every time and prevents potential oversights that could necessitate revalidation.
Alfa Laval Q-doc comprises conformity declaration, material certificates, relevant test certificates and information about necessary Alfa Laval spare parts kits for standard components. Just like the factory acceptance tests (FATs) for our separation systems, the Q-doc documentation package supports a smooth qualification and validation process, and safeguards long-term peace of mind.
Downloading Q-doc documentation package
To locate a Q-doc:
Customers can now download MRT, 3.1 and Q-docs on www.alfalaval.com/certificates
Download sample Q-doc:
Alfa Laval LKH UltraPure Pump
Alfa Laval Service Kit UltraPure
near Newsletter – Sustainable performance
Hygienic equipment for the food, dairy, beverage, pharmaceutical, personal and home care industries.
Today, sustainable development is high on all industries’ agenda. In Alfa Laval, we are committed to continuously improve our products and services to provide you with an opportunity to reduce your operation costs whilst improving environmental performance.
To keep you updated on important sustainability issues and opportunities in your industry and processes, we are launching our near newsletter which will come out monthly with focus on: Energy savings, efficiency gains, water savings, process optimization, and more!
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