Total pharma soloution and guide

1.0 OBJECTIVE 1.1  To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment. 2.0  SCOPE 2.1  This procedure applies to all aseptically filled sterile products intended for human use. 3.0  RESPONSIBILITY 3.1  The Validation personnel coordinate the aseptic filling validation program and write the sterile media aseptic filling processes reports. 3.2  Manufacturing personnel the sterile media aseptic filling processes and performs the sterile media fills. 3.3  QA personnel perform the sampling and assist with the IPQA monitoring required for each sterile media fill. 3.4  QC personnel to perform the testing and assist with the monitoring required for each sterile media fill. 4.0  ACCOUNTABILITY 4.1  Manager QA 5.0  REFERENCE (S) 5.1  In- house. 5.2Pharmaceutical Inspection convention Guidel...

             Basics of HVAC System HVAC system is a basic requirement of a pharmaceutical manufacturing facility. It has different parts those help to maintain the requiredtemperature and humidity in the manufacturing area. Air conditioning has changed over years, HVAC system is used to control the environment in the manufacturing as well as the storage area of the pharmaceutical facility.  Heating, Ventilation and Air Conditioning is a system that is used to control the air temperature by controlling the air filtration and the moisture in the air. This system is used to control the temperature of a designated space with the control of the moisture in the air, supply the area with fresh air by controlling the carbon dioxide and oxygen level. It alsocontrols the contaminationof airborne particles by regulating the movement of air. The HVAC system can effectively control the air conditions of a given paramet...

    Pharmaceutical and biotechnology manufacturing plants discharge different types of effluents and solid wastes. These effluents and solid wastes should be handled and treated carefully because they can cause a major threat to environment and biodiversity. As these wastes contain varieties of contaminants, if they are not treated before disposal to the environment, they can cause pollution. Industrial wastes are also a cause of contamination of soils. Sludge formed in industrial process destroy vegetation and result in formation of lifeless areas on earth surfaces. According to a report of Central Board for Prevention and Control of Water Pollution (CBPCWP), 1979, the industries of Mumbai accounts for 13% of total dump into water bodies. In Kolkata, 89% of wastes are of domestic origin. In Delhi, Yamuna receives about more than 200 million of untreated human wastes while the industries account for only 20 million liters of effluent. (Trivedi, R.K. and Goel,P.K. (1984...

http://totalpharmasoloution.blogspot.in Designing an air conditioning duct system is crucial while installing HVAC system in the enclosure. An improper design of HVAC system may not give that satisfaction of the comfort level as well as it may lead to a negative impact on your energy bill. Several parameters are considered while designing the duct system for air conditioning, such as the rate of airflow, energy load, proper positioning etc. Keeping in mind that the fans are fixed, the ducts are really used as a movable (or fixed in some cases) ventilator. Numbers of designs are taken under consideration for the available space to install the duct and the requirement.General Rules for Duct Designing *.Air flow should be direct that conserves energy, space and cost altogether. *.To reduce noise, air velocity should be within permitted range. *.Quality and recommended materials should be used to construct the duct. These materials should be smoother. *.If you are changi...

Chlorination and De-chlorination of Water System Effective concentration of chlorine and chlorination and de-chlorination of water system using Sodium hypochlorite and Sodium meta bisulfite Purified water is a basic requirement of any pharmaceutical company. Generally the source of raw water remains a bore well and raw water is stored in a storage tank. This raw water is stored for several days. These storage tanks are not cleaned for many days. Due to these situation problem of microbial growth would occur in raw water storage tank and  contaminate the whole water system. This is a common problem in pharmaceutical industries and generally solved by chlorination of the water storage tank. Sodium hypochlorite is used for chlorination of water. When sodium hypochlorite is dissolved in water is gives free chlorine that forms hypochlorous acid which actively takes part intensification process.Cl2+ H2O → HOCl + HCl Chlorine is a strong oxidizing agent that oxidizes organic compoun...

Purified Water Storage and Distribution System Learn about the purified water storage and distribution system and procedure for validation. The purified water is prepared by purified water generation system (Reverse Osmosis System) and collected in purified water storage tank of required capacity and distributed by a centrifugal pump for loop recirculation.At different points of use separate heat exchangeris provided (if required) to bring down temperature of hot circulating water as and when required. There is a back pressure valve in the return line. Instruments and on/off valve are for controlling and monitoring the system  operation and water quality. These are controlled from a centralized control panel consisting of a PLC board. The distribution piping consists of sanitary tubes, fittings, valves with orbital welding and triclover clamp in manufacturing area and for instrument connections. The water through this piping is supplied to various user points and circulated ...

pharmawatertreatment mportance and Method of De-gassing in Purified Water System Learn how is it important to de-gas the water treated with cation bed and the procedure of de-gassing using forced draft method. In pharmaceutical industries, bore-well is the principle source of the raw water.Raw water is purified by water purification systems to use in pharmaceutical manufacturing. Cation and anion beds are used to remove the hardness of raw water Degassers are used to remove the dissolved gases from the water. When water is passed through the cation exchange, carbonates and bicarbonate ions are converted into the carbon dioxide (CO2). Carbon dioxide is soluble in water, therefore; it is not removed from the treated water.This carbon dioxide increases the ionic load on the anion bed resulting in the more consumption of the sodium hydroxide. The efficiency of the anion resin is also affected due to this dissolved carbon dioxide. Degasser should always be installed after the ...