One of the most essential components in the manufacture of all pharmaceutical products is the validation of water in pharmaceuticals . Water system validation is essential to ensure that the specified quality of water is consistently produced. If you are a pharmaceutical manufacturer, it is certainly necessary to approve the water system for the production of your pharmaceutical products.
In fact, water is an important component of any pharmaceutical product, which is why it must be validated to protect the continued production of high-quality water. In the pharmaceutical industry, the quality of water used in the production of final products is the most important point to be considered. Analytical procedures are very important in the preparation of the intermediate reagent, especially in the case of injectable products where the water quality must be in accordance with the pharmacopoeia.
Medicinal water system quality must meet all regulatory requirements. There's no denying that any laxity in properly monitoring your water system can be costly for your manufacturing company as it leads to product recalls, wasted time and money. Validation of water system is necessary to gain knowledge of all physical, chemical, engineering and microbiological issues related to water production and distribution. 
It is important that the quality of the water should be specific to the quality of the product. Poor water quality can lead to product degradation, pollution, loss of product and profit. Usually, water contains organic and mineral impurities, microbial contamination, endotoxin, particle contamination, which can be unsuitable for the production of pharmaceutical products. In addition, it can have a strong effect on the quality and efficiency of the product. Water is a vital component in the production of pharmaceutical products. Even the distribution process can lead to contamination. This is why water system validation is an important aspect of manufacturing plants in the pharmaceutical industry.
It is mandatory for factories to ensure the validation of water in pharmaceuticals to comply with regulations.
To ensure reliable and consistent production of water for consistent quality.
To prevent unacceptable microbial, chemical and physical contamination during production, storage and distribution.
Grades of water for medicinal purposes
Potable
water Pure
water Water for injection ( WFI )
Sterile water for injection and inhalation.
Sterile bacteriostatic water for injection - validationValidation and quality assuranceWater System Qualification
- Water in the pharmaceutical industry
- Preparation of the necessary documents for the implementation of the validation protocol of the purification system, preparation, storage and distribution of medicinal watersValidationand quality assurance(Qualification)
- Preparation of the necessary documentation for the treatment and medicinal water supply unit (executive method, instructions, form, logbook, map, water system manual, etc.)
- Improving and optimizing the system of preparation and production of medicinal waters (pure water, injected distilled water and clean steam) in accordance with international standards such as PIC/S - WHO - USP - FDA - ISPE - ASME
- doDQ, IQ, OQ, PQ for the system of preparation, storage and distribution of medicinal waters according to the client's needs
The conditions of validation of the water system in the pharmacy must be in accordance with the requirements of the Pharmacopoeia. A proper sampling system of the right points with the right frequency.
Identify and solve common contamination problems. To consistently produce water that meets industry standards for quality
. Procedures for operating the water system and performing routine repairs and corrective actions should be written and should also identify the point at which action is required.
A proper monitoring program is a critical quality attribute and operating parameters must be documented and monitored. This program may include a combination of in-line sensors or recorders (eg, conductivity meters and recorders), manual documentation of operational parameters (eg, carbon filter pressure drop), and laboratory testing.
A routine disinfection should be performed according to the system design and selected operating units to maintain the system in a state of microbial control. A preventive maintenance program is important to determine what preventive maintenance should be performed, how often the maintenance work should be done, and how the work should be documented. Various techniques are used for water purification: - Dechlorination (sodium bisulfate carbon filter)
- filteration
- Ultra filtration
- to soften
- Demineralization
- reverse osmosis
- UV treatment
- Deionization
- ozonation
- Various equipment and components for water system
- piping
- faucets
- Pumps
- Pressure measuring instrument
- Heat Exchangers
- Distillation unit
- Filters
- Deionizers
- Sensors
- Auxiliary equipment
Revalidation of water in pharmaceuticals
Preparing the protocol
Preparation of instructions for the repair and maintenance of the water system, including: instructions for the maintenance and repair of water validation in the pharmacist - instructions for cleaning and replacing lamps and quartz glasses and washing the UV device- Instructions on how to replace the filters of the water making room equipment - Instructions on how to work with the water making machine - Instructions for descaling and washing the membranes of the water making machine - Instructions for washing and disinfecting the machine, path and tanks of the water making machine - Instructions for chlorination of raw water - Instructions for calibrating precision instruments - and .....
Preparing documents for water purification systems according to the standards and principles approved by the employer and providing documentsIQ andOQ and doValidation of the pure water production device should be done firstTo be qualified means the following steps must be done first: - Design Qualification (DQ)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Performance Qualification (PQ)
This stage itself consists of three phases
To prepare the validation protocol for pure water production systems Purified water generatorThe following should be mentioned :
* Purpose:
The purpose of developing the protocol is to make sure that the water system is in accordance with the approved design, the manufacturer's recommendations or the consumer's requirements.
* Scope :
the scope of application must be specified, which units this protocol is related to.
* Responsibilities and powersResponsibilitiesIn this matter ,
the responsibilities and authority of people such as installation supervisor, technical manager, quality assurance unit, quality assurance manager, etc. should be specified separately.
For example:
- The person supervising the installation performs the quality assurance and documents the resulting information.
- The technical manager is responsible for checking the records and confirming them and the installation quality verification report.
- The quality assurance unit is responsible for reviewing the installation quality assurance protocol.
- The quality assurance manager is responsible for approving the protocol.
Preparing specifications of devices and equipment including:
- General description of the operation and description of the water supply system or equipment or the installed equipment and its main components
- Preparing a list of the main components of the water supply system and equipment including: pressure pumps and circulators - activated carbon and cartridge filters - membranes - precision instrument equipment (conductivity meter - Phmeters - flow meters - level controllers - and...) - device valves and sampling and consumption - water storage tanks - electrical and electronic equipment - soda injection and antiscalant equipment - bisulfite and .... UV system- Pressure gauges - Pipes of the device and water loop path for consumption - CIP equipment-
Preparation of required facilities information for waterworks devices and equipment including: water well (submersible pump - length and diameter of communication pipes - well depth - wall pipe diameter) - raw water storage tank (volume - material) - chlorination (chlorine retention tank - Chlorine injection pump - Chlorine preparation mixer) - Communication pipes - Types of filters that are installed in the raw water path -
* Preparing a list of implementation methods and related instructions
* Determining the standards
* Description of validation type and repetition time
* Definition of predetermined acceptable ranges for drawing conclusions
* Reports and records ( Records) including:
- how to report
- deviations report (deviations - reason for acceptance - impact on performance)
- installation qualification report (results - conclusions)
- change control Additional chapters of the course:
Types of medicinal water based onBP, USPAndEP
types of medicinal water purification systems
Medicinal water storage and distribution system
Technical Specifications(Specifications)The components of the water system such as: voltage and electric power and flow of electric parts - name of the country and manufacturer - dimensions of the part - installation location - type and type of valves used - type and type of pipes of the device and the path of the water supply loop for consumption - specifications of precision instruments - Specifications of tanks - Specifications of filters - Specifications of UV system- Specifications of pressure gauges - Specifications of CIP equipment- Specifications of membranes - Specifications of tanks and equipment for chlorine and soda injection and antiscalant and.... -
Design principles of medicinal water purification and purification system
Important indicators of water in the design and quality control of the water system
Types of water purification methods(Ion-Exchange, UF, RO & Distillation)
Familiarity with water purification steps in order to obtain deionized water
Application and justification of the use of various purification methods
The principles of operation and implementation of the water purification system process
Based on the guidelines of PIC/S - WHO - USP - FDA - ISPE - ASME
, checking the flow diagrams of the water system and expressing their characteristics
CIPReverse osmosis membranes to increase the efficiency and longevity of the membranes
different waysSanitization to maintain the Passivation water purification system
For optimal maintenance of loop and hygienic equipment(ASTM)
set up water system(Start-up & Commissioning)
Verifying the quality of the water purification system and validating the medicinal water preparation process
Monitoring, inspection and maintenance of the water system
Medicinal water quality control tests
Microbial control of
URS medicated waterwater system
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