How to Comply with Regulations & Guidance for Water & Steam Systems
The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing Practice (GMP) regulations while remaining in compliance with all other governing codes, laws, mandates, and regulations.
The ISPE Baseline® Guide: Water and Steam Systems 3rd Edition focuses on engineering issues and provides innovative and technologically accepted solutions and alternatives for water and steam systems. The Guide was written by a global team of critical utilities experts with a combined experience of more than 500 years.
Nissan Cohen, Guide Contributor (Co-Lead), shares his insights on how the Guide is by far “The best document that exists in the world for pharmaceutical water. The guide encompasses all the different pharmacopoeias that we have to comply to for compendium issues, so this particular document is not only an incredible resource and reference, it is also an incredible application of subject matter experts, who have taken their time in order to produce a 262 page document that covers everything that you ever wanted to know about water and steam systems,” said Cohen.
This latest version describes new variations in the European Pharmacopoeia for the manufacture of water for injection (WFI) by methods other than distillation. “Its value is an easy reference in order to show how to meet compendious, and how to designs systems that will not only perform, they will perform for the next 20 years. Now that the European pharmacopoeia, the United States pharmacopeia, the Japan pharmacopoeia, and the China pharmacopoeia are now harmonized, we now have the availability for people to choose all different kinds of methodologies to produce water for injection, rather than only by distillation, that was one of the main aspects of the changes in this current document,” said Cohen.
Additional changes include discussions on the global harmonization of water quality attributes, comprehensive pretreatment design, rapid microbial monitoring, ozone for ambient sanitization, and membrane technologies. “Water for injection primarily was using the gold standard, which was distillation for Eons, so the idea of distillation and distilled water goes back almost 200 years in the pharmacopoeia. The difference today is that we have different technologies in order to purify water, which allows us to have multiple modules that can be used in order to define water for injection water quality. It is the quality of the water which defines water for injection, not its method of production, so what we have done since 2002 is given the industry a lot of latitude as long as you meet the criteria for four different parametric values of microbial, endotoxin, toc, and conductivity. You meet the microbial values, you have water for injection water, and it doesn’t make any difference how its generated,” said Cohen.
Industry professionals will expand their knowledge and benefit with great resources by using the Guide, “We are giving the industry that latitude to make those decisions that they would consider best for their particular product line. This particular guide offers you the most comprehensive explanation of design, QbD, regulatory, it has probably the best chapter on microbial that exists in the pharmaceutical industry as far as knowledge of what needs to be done from a microbial standpoint. Everyone in the pharmaceutical industry is a water expert, every individual, every person in the pharmaceutical industry needs water in order to produce pharmaceuticals. Whether they be oral solid dosage, liquid-filled, or water for injection water, even shampoo and over the counter products all use water. All of us need to be knowledgeable of the water that goes into our products and we are the people who help set those standards to make sure that you are compliant,” said Cohen.