Water is essential for life and to almost every manufacturing business one can think of. While water used for domestic needs varies largely in its quality, water used for pharmaceutical operations is strictly process-oriented. Purified water for pharmaceutical use is a broad term with many variations. From their process of manufacturing to their chemical and biological makeup, purified water for pharmaceutical use can be dynamic and complex.
Types of Purified Water
When it comes to pharma, purified water can mean a lot of things. Depending on their use case, purified water used in the pharmaceutical industry may include:
Purified Water
Purified water is a grade of pharmaceutical water that is free of chloride, calcium, sulfates, ammonia, carbon dioxide, and heavy metals. Purified water is derived using the process of reverse osmosis, EDI, or distillation.
Some of the most common uses of purified water are in the preparation of oral and topical products, cleaning equipment, and as the feed water for WFI (water for injection)
Water for Injection
Water for injection or WFI is the highest quality of water used for pharmaceutical purposes. Water for injection is mainly used for preparing products that are directly injected into the bloodstream of the patient.
WFI is free of endotoxins as well as other common pollutants and is prepared using the process of distillation.
Highly Purified Water
Highly purified water (HPW) is a unique specification of water quality found only in the European Pharmacopoeia. It has the same microbiological and endotoxin specifications, such as WFi, and must be protected from recontamination and microbial proliferation.
Water for Hemodialysis
It is a type of water that is used for the process of dialysis, which is a common treatment for people with kidney malfunctions. It is prepared by using the process of initial filtration and then reverse osmosis. Salts such as sodium and bicarbonate are also added to it, and its main function is to flush toxins from the body.
Sterile Water for Irrigation & Inhalation
Sterile water for inhalation is essentially WFI that can be used for making inhaling solutions. However, the endotoxin levels for the same are not as strict as WFI, and hence it cannot be used as a parenteral solution.
Sterile water for irrigation is also WFI that is packed in bottles with a capacity of not more than 1 litre and is meant for rapid transit. The main purpose of sterile water for irrigation is to bathe and moisten the tissues, especially during critical surgeries.
Good Practices for the Manufacturing of Purified Water for Pharmaceutical Use
Different water in pharma has a different use case and a whole set of manufacturing processes dedicated to it. As one of the most strictly regulated manufacturing industries in the world, the pharmaceutical industry is constantly under intense scrutiny. The international regulatory bodies have formulated a specific set of rules and standards that every pharma manufacturing unit has to abide by, irrespective of the difference in scope and capacity.
While the cornucopia of operations remains dynamic, there are some common practices that are a good idea for every manufacturing unit to model their operations on. Collectively, they are called Good Manufacturing Practices or GMP.
Design
For any manufacturing unit to operate smoothly, design is an integral factor, if not the most important one. For pharma and especially water purification plants in pharma, it is important to have a design in place that is intentional, customized, flexible, and easy to maintain. From the size of the storage tanks to the optimal temperature or the design of the pipes, having a solid design approach at the onset is not only a sure-shot way to keep the operations running smoothly but is also a smart strategy to avoid costly do-overs in the future.
Quality
No business in the world has survived for long without being obsessed with quality. In pharmaceuticals, given the sensitive use case of the end products, cutting corners is simply not an option. A manufacturing plant can only produce superior quality products when the raw material and equipment used, as well as the staff taking care of all the processes, are of superlative quality.
Manufacturing plants often make the mistake of installing superior quality equipment but compromise on the quality of the feedwater. It not only compromises the integrity of the end but also risks the expensive paraphernalia.
Standardization
Pharmaceuticals is not a short-term business. It is not enough to produce good quality products once; there is a need to standardize the process so that it can continue producing superior results. Maintaining proper manufacturing conditions in terms of raw materials, proper documentation, equipment, training, and personal hygiene of staff should not be something that manufacturing units do once in a long period of time. Standardizing the processes ensures the same output quality no matter what.
Do Pharma Companies Benefit from GMP?
On the face of it, cutting corners during manufacturing may sound like an easier way to make profits; however, skimping on quality never makes for a wise business decision. Making bad quality products is not ‘cheaper’. Rather it paves the way for catastrophic mistakes with really expensive amends. Investing in quality is the smartest decision which not only makes way for better business operations but also gives credibility to the pharmaceutical industry as a whole. Such an approach can be a huge impetus to boost the healthcare structure and approach of different countries and the world as a whole.
Purified water for pharmaceutical use is not just another product that anyone can be trusted with. It is essential to ensure that the best production practices are being followed to treat the most important resource in pharma. Thus, we cannot stress enough the importance of working with a partner that follows all the current Good Manufacturing Practices while designing, installing, and validating the pure water system. TSA Water System is a leading designer and manufacturer of pharmaceutical pure water systems in India. Our team of experts makes sure that your pure water unit is set up as per the guidelines in GMP. We empower your pharmaceutical manufacturing processes with robust pure water systems to produce consistent quality results.
