The use of water in formulation of pharmaceutical products goes beyond being a solvent in that water is also used in cleaning and sanitation purposes. Water quality affects the safety profile, and the performance of the pharmaceutical products that are produced, thus, water treatment equipment needs to be optimized. This paper aims to focus on the main ways to improve the performance of water treatment in order to fulfill the specifications of pharmaceutical manufacturing, conformity, effectiveness, and economy.
Importance of Water Quality
This is because water is used in almost all the processes involved in the production of drugs, including formulation of the substances to be used in the drugs and for cleaning of the equipment to be used in the production of these drugs. Water can get contaminated hence affect the quality of various drugs causing them to be less effective or even hazardous to the patient’s health. This has shifted the responsibility of SPE to ensure pharmaceutical equipment manufacturing organizations devise water treatment systems that yield the finest quality water.
Pharmaceutical water as defined for use in the manufacturing processes has to meet very strict prescriptions currently within the USP and EP. These standards set the allowed concentration of any impurities such as endotoxins, microorganisms, organic or inorganic matter and others. It is important for water treatment equipment to meet these standards and remain consistent hence the need to ensure that it does meet the required standard before it is released into the market.
Key Water Treatment Technologies
Effectiveness of water treatment equipment lays guidance in the choice of the right technologies that can adequately treat water to the recommended standards. Several technologies, such as reverse osmosis (RO), ultra-filtration, deionization and ultraviolet light disinfection are widely being used in the production of pharmaceuticals.
Desalination by reverse osmosis is one of the most common techniques which by using the pressure forces water through a semipermeable membrane which separates dissolved salts, organic molecules and other impurities. Another important technology is ultrafiltration that is very useful in bacteria, pyrogen, and high molecular weight rejection. Deionization takes water through a process of removing ionized salts while UV disinfection is a process of disinfected water with microorganisms without involving addition of chemicals to the water.
These technologies must then be incorporated into the pharmaceutical equipment manufacturer’s water treatment systems to effect the required water quality. These technologies can be integrated to various extents depending on the entire manufacturing process, the quality of the source water and the permissible limits of the pollutant discharge.
System Design and Configuration
This paper examines the part that design and configuration of water treatment systems has in the optimization of the systems. In the case of the system, good design means that in addition to achieving the necessary parameters of water quality, little energy is spent to maintain the efficiency of utilizing water.
The selection of water treatment process in any water treatment system for pharmaceutical manufacturing involves the following factors namely quantity of water, quality of source water and the demand from the manufacturing process. For example, if a pharmaceutical plant needs very much water of very high quality, then the system has to cater for this requirement as well as other requirements in terms of production capacity, quality and other factors.
Also, system configuration should permit expandability and flexibility of use of the system. If there are alterations in the production requirements or new specifications introduced by the authorities, the type of water treatment that is to be used should be easily capable of being modified. Buying capsule filling machines and related equipment must make it a requirement that their water treatment systems are expandable as well as upgradable in the future.
Maintenance and Monitoring
To guarantee that the water treatment systems continue to perform effectively, there is the need to undertake routine checkups and repair work. In fact even with these systems, a lot of attention is still needed in the form of inspection at regular intervals, cleaning and replacement of the components.
Supervisory systems are typical means of modern water treatment equipment. These systems monitor such important parameters as the water quality, flow rate and system pressure all the time, with the updated information that can be useful to spot problems of varying severity before they occur. For instance if a filter within a reverse osmosis system has become compromised through a build up of particles the monitoring system can indicate to the operator that a filter needs to be changed to maintain water quality.
The companies dealing in manufacture of pharmaceutical equipment should ensure that the water treatment systems they provide are serviced adequately by coming up with an elaborate service plan with or without a monitoring system in place. This is not only protective of expensive pieces of equipment but also safeguards the company from nonconformities to regulatory requirements.
Regulatory Compliance and Validation
In the pharmaceutical manufacturing industry, there are regulatory requirements that have to be adhered to with regard to waters used in the production of drug and water treatment equipment hence has to be validated to meet these standards. Validation is the process of proving that equipment is capable of producing water that meets the quality standards time and again the process involves testing and documenting.
For pharmaceutical manufacturers this entails a close collaboration with equipment suppliers to have water treatment equipment fully validated. It involves the assessment of installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) to show that the system meets its required function.
Water treatment suppliers who offer systems to pharma equipment manufacturers need to offer critical validation support to the customers with well-documented documents and training to the operators. This helps in fulfilling the legal obligations of the equipment and also in maintaining a good level of performance all through the useful life of the equipment.
Water treatment and its equipment play critical roles in pharmaceutical productions, and hence proper optimization of the equipment will enhance production of the pharmaceutical. This is due to appreciation of water quality, adequate selection of treatment technologies, treatment systems , fabrication of efficient systems and monitoring as well as maintenance and compliance with regulatory authorities.
Companies operating in the pharmaceutical equipment manufacturing industry thus have the responsibility of ensuring that they design and supply equipment that provides optimization of these processes to the pharmaceutical industry. From capsule filling machines to water treatment systems, there is always equipment that a pharmaceutical firm will require to purchase and another that should be installed to meet production requirements, and the choices made will determine the efficiency of operations in the end.