Laporan Praktek Kerja Profesi Apoteker IKOP Sdn. Bhd. – Malaysia Periode April 2019 PRACTICAL INTERNSHIP REPORT ENGINEERING DEPARTMENT IKOP Sdn. Bhd. - MALAYSIA GROUP MEMBER: Yogie Andika Tri Nanda Tesha Paramitha Illah Rahmawati Tri Senja Aprilia Setya Dewi Wulandari Agustha Veronika Hafizh Prasetyo Syarif Hidayatullah Thanthawi Nurkurniawan Meri Ulfa Kartika Inshiana Wisnu W UII UII UII UII UII UII UII UII UII UII UII DATE OF PRACTICE : APRIL 9th, 2019 DEMONSTRATOR : ABDUL RASYID ZAHARI Laporan Praktek Kerja Profesi Apoteker IKOP Sdn. Bhd. – Malaysia Periode April 2019 Introduction Heating, ventilation, and air conditioning (HVAC) system is designed to achieve the environmental requirements of the comfort of occupants and a process. HVAC systems are more used in different types of buildings such as industrial, commercial, residential and institutional buildings. The main mission of HVAC system is to satisfy the thermal comfort of occupants by adjusting and changing the outdoor air conditions to the desired conditions of occupied buildings. Depending on outdoor conditions, the outdoor air is drawn into the buildings and heated or cooled before it is distributed into the occupied spaces, then it is exhausted to the ambient air or reused in the system. The selection of HVAC systems in a given building will depend on the climate, the age of the building, the individual preferences of the owner of the building and a designer of a project, the project budget, the architectural design of the buildings. System selection depends on three main factors including the building configuration, the climate conditions, and the owner desire. The design engineer is responsible for considering various systems and recommending more than one system to meet the goal and satisfy the owner of a building. Some criteria can be considered such as climate change (e.g., temperature, humidity, and space pressure), building capacity, spatial requirements, cost such as capital cost, operating cost, and maintenance cost, life cycle analysis, and reliability and flexibility. Utilities Utilities are units that produce, provide, and distribute commodities required to support manufacturing operations. Typical pharmaceutical utilities are heating, ventilating and air-conditioning (HVAC) system and purified water system (PWS) 1. Heating, Ventilating And Air-Conditioning (HVAC) System HVAC system conditions the environtment throught the control of temperature, humidity, air movement and air quality. Air quality parameter that may affect product are temperature, relative humidity (RH) and airborne contaminations (viable and non-viable particles). HVAC system controls airbone contaminations through supplying air in sufficient volume and maintaining room pressure; either positive or negative with respect to the adjacent areas. Laporan Praktek Kerja Profesi Apoteker IKOP Sdn. Bhd. – Malaysia Periode April 2019 Figure 1. A typical HVAC system. Purpose of Test In this practical session we will be demonstrated on the use of a thermohygrometer for measurement of air temperature and RH, a particle counter of the measurement of airbone contaminants, a pressure gauge for the measurement of differential pressure between adjacent areas and an air balancing instrument for the measurement of air change rate (a measure of how quickly the air in an interior space is replaced by supplied air. If the amount of air that enters and exits in one hour equal to the volume of the cleanroom, then the ACR = 1 airchange per hour (AC/h). We will measure those parameters for three selected rooms in the production plant. a. Procedure for Temperature & Relative Humidity Test Purpose: To determine the capability of the Cleanroom Air Handling System to maintain the air temperature and relative humidity within specified limits Instrument: Thermohygrometer Specification: Test Condition : At rest Temperature : 22◦C ± 2 Relative Humidity : ≤ 70% Laporan Praktek Kerja Profesi Apoteker IKOP Sdn. Bhd. – Malaysia Periode April 2019 Procedure: Hold the thermohygrometer at point of at height of 1 meter from the floor Place the thermohygrometer at the point of temperature mapping. Capture the temperature and humidity Reading was recorded after stabilization. b. Procedure for Airbone Particle Count Purpose: To measure the airborne particulate level in the Cleanroom and to determine the room cleanliness classification. Instrument : Particle Counter. Spesification: Test Condition : At rest Class Limits : ≤ 3,520,000 @ 0,5 µm ≤ 29,000 @ 5,0 µm Procedure Set the counter’s sample rate 1 cfm and the sampling time to 1 minutes. Place the sampling probe inlet in the direction of the airflow. Press the start button. Reading was recorded after the counter stop. c. Procedure for Air Flow Volume & Air Change Rate Test Purpose: To determine the Airflow Volume and Total Air Change Rate per hour of the Cleanroom. Instrument: Electronic Micromanometer & Flowhood Laporan Praktek Kerja Profesi Apoteker IKOP Sdn. Bhd. – Malaysia Periode April 2019 Specification: Test Condition : At rest Average Velocity : ≥ 20 Procedure: Place the Flowhood over the diffuser at the top of room. Open the backpressure flap. Press the red switch. The message “OPEN” will be displayed. Wait for the message “CLOSE FLAG” the close the flap by pulling down the flap handle until it clicks into the fully closed position . 2. Purified Water System (PWS) Water purification system at IKOP Sdn Bhd is to produce purified water. The purified water is an essential ingredient of various non-sterile pharmaceutical preparations and is also used to clean process equipment and production floor (except at tertiary packing). It is also graded based on various quality parameters such as conductivity, total organic carbon (TOC), microbiological values, and presence of contaminants including nitrates and heavy metals. Figure 2. Water Purification System at IKOP Sdn Bhd Laporan Praktek Kerja Profesi Apoteker IKOP Sdn. Bhd. – Malaysia Periode April 2019 No Stage Purpose 1. Multimedia Sand Filtration Removal of debris and particles down to 20 µm 2. Water Softener Removal of hardness (calcium and magnesium salts) 3. Activated Carbon Removal of organic matters, foul odor and disinfectans (chlorine) Removal of particle down to 3 µm 4. 3 µm Media Depth Filtration Removal of particle down to 1 µm 5. 1 µm Media Depth Filtration 6. Ultra-filtration Finer removal of particulate matters (down to 0.01 ppm) 7. Double Pass Reverse Removal of dissolved minerals, particulates, bacteria, viruses and pyrogen. 8. Mixed-bed Ion Exchange Polishing unit to a further removal of ions (both cations and anions) 9. Ultra-violet (UV) light Reduction of bio-burden in the purified 10. Pure Water Storage Tank water Storage of the purified water Laporan Praktek Kerja Profesi Apoteker IKOP Sdn. Bhd. – Malaysia Periode April 2019 Results Room 1 Wash room 3 Parameter o Temperature ( C) RH (%) Granulation & Drying room Powder sieving, milling & mixing room 19.7 66.8 20 65 19.5 67.8 0.5 µm 0.5 µm 0.5 µm Particle Count 3 (Counts/m ) 9440.76 ; 10429.43 ; 3484.2 ; 5131.4 Differential pressure with adjacent corridor (Pa) rate 8346.03 ; 8863.96 ; 4873.43 ; 6121 5.0 µm 5.0 µm 247.23 ; 141.23 ; 94.16 ; 47.06 Air change (Ac/h) 6333.067 ; 4743.96 ; 4649.73 ; 4979.3 ; 5720.97 ; 4638 15 12.99m 258.96 ; 247.23 ; 129.46 ; 94.16 5.0 µm 70.6 ; 82.4 ; 47.06 ; 94.167 ; 94.167 ; 94.167 15 3 5.81m 18 3 7.89m 3 Discussion In this engineering practical session, we have measure five parameters above for three selected room in the production plant. The rooms are powder sieving, milling and mixing room, granulation room, drying room and wash room. Based on the result, the temperature, RH and the airbrone particulate level in the three room were in the spesification. Beside that, air change rate in the three rooms were out of the spesification, because of these rooms are less maintenance. Total air change rate as well as particle count are affected by the room filter, so the filter must be maintained properly, on it’s spesifications. Laporan Praktek Kerja Profesi Apoteker IKOP Sdn. Bhd. – Malaysia Periode April 2019 Conclusion The rooms in the production pilot known as clean room. So, the air handling system must be maintained properly, because its system maintain room temperature, relative humidity, room pressure, as well as particle count and air change rate and that will have impact on the product.
