WATER SYSTEM:
- A purified Water system is a basic requirement for Pharmaceutical Industries.
- Raw Water sourced from industry bore well water is converted into purified water complying with current USP/ BP/ IP/ Ph. Eur.
GENERATION OF PURIFIED WATER:
- The raw water passes through a sand filter through a transfer pump. This will remove solid particles 10µ to 40µ.
- After the pressure sand filter pass from the softener to remove the hardness up to 5ppm and store in the soft water storage tank.
- Dosing of Antiscalent to reduce the scale Forming Tendency of water,
- Sodium Meta-bisulphate is given to excess chlorine this has a check of ORP (Oxidation Reduction Potential) accompanying the automatic valve to dump the water if it is not chlorine-free and NaOH dosing system for pH balancing, and then pass from cartridge filter through transfer pump.
- Water is feed into the RO-I system with RO high-pressure feed pump then store in the RO-I water storage tank and
- Then Pass into RO-II by a high-pressure feed pump which in turn reduces conductivity up to less than 10µS/cm. and
- Then into EDI- The conductivity of water after the EDI unit is less than 1.3µS/cm and microbial limit less than 100cfu/ml. and
- Then pass through HSEDI water is stored in SS316L Purified water storage tank of capacity 3 KL & distributed to all user point by means of recirculation pump & distribution loop through UV installed at starting of PW supply loop.
- The purified water storage & distribution system is designed for continuous recirculation, if there is a shutdown or the system fails.
- Purified water is the purified water storage tank must be drained and System sanitization has to be done before restarting the system.
The generation, storage & distribution system is controlled by the centralized control panel, critical parameters viz.
- Tank level,
- Return line conductivity,
- Return line temperature,
- Return line flow will be continuously monitored,
- Controlled & data logged in the printer provided.
- The distribution loop is pressurized & continuously under recirculation.
- The minimum velocity to be maintained in the return line during consumption is 1.2m/sec.
- The system has the facility of sanitization at a suitable frequency.
- The system is hot water sanitization, a CIP system for chemical cleaning of the membrane periodically as per SOP or any seasonal change.
- The CIP system consists of all equipment to perform the necessary functions for the chemical cleaning of the system, Centrifugal pump shall be used in the CIP system to transfer chemical solution from tank to respective system.
- Water in the storage tank is kept under continuous recirculation.
Material of Construction of Vessels and Pipe Work:
The material of construction of pipes used for raw water supply is galvanized iron.
Purified water is supplied to production areas through SS 316L pipelines.
The storage tank is mechanically polished and buffed outside and made up of SS 316L.
Water for Injection Quality
The quality of water collected in the storage tank after final treatment complies with current USP/ BP/ IP/ Ph. Eur. standards including
- pH between 5 to 7,
- Conductivity not more than 1.3 mS/cm,
- Total Microbial Count not more than 10 cfu/ 100 ml,
- Total Organic Carbon (TOC) not more than 500 ppb.
Quality is regularly monitored throughout the system. The action and alert limits are specified.
Sampling Points and Frequency of Sampling:
- Routine sampling and testing are done in order to assess the quality of water produced.
- During water validation all sampling points, storage, and return points are subjected to chemical and microbiological analysis on daily basis up to the completion of phase-I (2 weeks), phase-II (2 weeks), and phase –III (up to 12 months).
- After completion of the validation study, all user points are sampled and the return loop, storage tank are sampled on daily basis.
- A detailed describing operation and sanitation procedure for water for the injection system is available in SOP and needs to follow during the routine handling of the water system.
Water for Injection System:
- The purified water storage tank is supplied to water for the injection system and based on the distillation, multicolumn is installed at the service floor.
- During water for injection system validation all sampling points, storage, and return points shall be subjected to chemical and microbiological analysis on daily basis up to the completion of phase-I (2 weeks) and phase-II. (2 weeks). And phase –III (up to 12 months).
- After completion of the validation study, all user points are sampled once a week and the return loop, storage tank are sampled on daily basis.
- Water for injection is used as an excipient in the production of parenteral and other preparations where product Endotoxin content must be controlled and in other pharmaceutical applications, such as cleaning of certain equipment and parenteral product contact components.
- A detailed describing operation and sanitation procedure for water for the injection system is available in SOP and needs to follow during the routine handling of the water for the Injection system.
- The multicolumn distillation plant for Water for Injections with a capacity of 150 liters/hr. cGMP model and Storage tank with 2000 liters.
- Under continuous supply with circulation loop system at the desired temperature with an online recording of Temperature and conductivity and TOC.
