Water treatment system (SPA) is a system to obtain water with the quality required by each type of drug that is made and meets the requirements of the pharmacopoeial monograph. Water plays an important and critical role in the pharmaceutical industry because it is the starting material to ensure the production of quality and safe drugs for users. Because of their important role, these SPAs need to be properly designed, manufactured, commissioned, qualified, operated and maintained to achieve their intended use. The replacement of the water treatment system from manual to automatic also needs to be qualified which will later be able to guarantee the quality of the water used in drug production, as well as other activities in the pharmaceutical industry. For this reason, it is necessary to intervene from water treatment companies to run successfully
The summary of the table above is the pure water requirements that are required in every pure water quality test. However, in the Operational Guidelines for the Implementation of GMP Guidelines, it is also explained that bacterial testing is also added with testing for pathogenic bacteria. The source of water used by the Pharmaceutical Industry can come from surface water sources taken directly from river water, PDAM or well water, so it is necessary to carry out a water purification process to meet the purified water criteria mentioned above. Therefore, the supply water will be processed in a tool called the Purified Water System with the schematic of the tool in the figure below.
The purified water system consists of: Multimedia filter, Carbon filter, Water softener, Heat Exchanger (HE), Micro filter, Ultra filtration (R.O = Reverse Osmosis), and Electro De-Ionization (EDI) with functions described as follows:
Multimedia filters. Multimedia filter serves to remove mud, sediment and particles contained in raw water. Multimedia filter consists of several filters with a porosity of 6-12 mm; 2.4 – 4.8 mm; 1.2-2.4 mm; and 0.6-1.2 mm. These filters are arranged in one vessel (tube) with the bottom of the tube given gravel or sand as the base of the vessel (so it is often also called a sand filter).
Active Carbon filters. Activated carbon is carbon that has been activated using high pressure steam or carbon dioxide (CO2) derived from materials that have a very high adsorption capacity. Usually used in granular form (granules). Active carbon functions as a pre treatment before the de-ionization process to remove chlorine, chloramine, benzene, pesticides, organic materials, color, odor and taste in water.
Water Softener Filter. Water softener filter contains anionic resin which functions to remove and/or reduce water hardness by binding to Ca++ and Mg++ ions which cause high water hardness levels.
Reverse Osmosis. Reverse osmosis is a technique for making purified water that can reduce up to 95% of Total Dissolve Solids (TDS) in water. Reverse osmosis consists of a very fine filter layer (up to 0.0001 micron)
EDI (Electronic De-Ionization). EDI is a development of the Ion Exchange system where as a binder of (+) and (-) ions are also used in addition to the resin electrode. This electrode is connected to a direct current so that the water purification process can take place continuously without the need for regeneration. After passing through the EDI, the purified water produced is then stored in a storage tank equipped with CIP (cleaning in place) and a looping system and ready to be distributed to the production room.
The Water Treatment System is a critical system that has a direct impact on quality, so the critical quality parameters of the system must be qualified. The qualifications to be carried out must follow the validation rules which include Design Qualifications (KD), Installation Qualifications (KI), Operational Qualifications (KO) and Performance Qualifications (KK) in accordance with GMP Guidelines. KD, KI and KO are very dependent on each system installed by each pharmaceutical industry, so the Technical Guidelines for GMP do not provide specific guidelines. Technical Guidelines for CPOB (and also POPP CPOB) only provide guidelines regarding the implementation of KK (Performance Qualification) with a 3 phase approach, namely phase 1, phase 2 and phase 3 which are summarized as follows:
