Agappe MD’s Desk C) atmosphere for handling critical products. Incremental positive pressure for maintaining contamination free zone is recorded through Magnahelic guage.
5. Dedicated and integrated Hematology Plant
In the new facility, we have provided 20000L capacity, SS 316L tanks with integrated filling line. In the Hematology plant, terminal filtration of sterilizing grade of 0.2 micron filter is employed for excellent quality products. Process is under Grade 8 environment with dedicated automated filling lines, in closed system including mixing, Air Handling Unit (AHU) transfer and filling without manual intervention. Dedicated independent online facilities are proThe temperature and humidity in the production critical vided for each activity like dress change, dispensing, mixing, fillrooms and areas served by the HVAC system shall be moni- ing and cartooning of the flexibags to eliminate contamination. tored by the Building Management System, BMS system. All the temperature and RH conditions are recorded in supervi- 6. Rain Water Harvesting as an alternative source for water Agappe utilises ‘the God-given’ principal ingredient, water, for sory control server. the manufacture of its IVD Reagents. The factory is situated on a Adequate air changes per hour to ensure proper supply of hill in central Kerala where the ground water is scarce. However, clean air. with its tropical climate, the state is bestowed with two seasons, namely summer with rain and summer without rain. Usually, the 2. Lyophilisers monsoon showers are drained off completely through the nuLyophilisation is a process by which we make stable prepa- merous streams and rivers to the sea, which is only 25 km away. rations of a relatively unstable biological substance by rapid The factory at present uses about 35-40 KL per day of raw freezing and dehydration of the frozen product under high vacuum. Agappe’s new facility provides two Lyophilisers, water per day. It is in this context that the company ventured into which can hold 7000+ vials at a time, which operate in class ‘rain water harvesting’. The company is having a building com100,000 for better quality and non-contamination. Automatic plex with a total built-up area of about 1, 20,000 square feet. All the filling and bunking equipment is attached to the Lyophiliser building roofs are connected together with pipe networks for colarea, for direct loading to the Lyophiliser units, once pre- lecting rain water and fed to a sand filter prior to storing in a natural quarry, having a storage capacpared. These Lyophilisers are systemity of about 6 million litres of water. controlled without any human intervenThe quarry is protected with a special tion, once the cycle is programmed. type fabric to prevent evaporation loss 3. Ultra Low RH by specialised and dust contamination.
Dehumidification
7. Water Treatment Plant
Specialised Dehumidification system is integrated with the AHU for maintaining ultra-low Relative Humidity. The two low RH areas of 20% and 10% are specially designed for the manufacturing of Advanced Rapid Products and active enzyme formulation. Live monitoring of RH through Building Management System (BMS) is an added advantage to monitor process control in place.
4. Laminar Air Flow (LAF) Class 100 (Grade A) LAF work stations are placed in class 10000 (Grade
10
TECHAGAPPE
APRIL-JUNE 2016
Lyophiliser
We have a dedicated 24x7 water treatment plant for the raw water collected. Water is treated with mixed bed of Sand filter, containing sand, activated carbon, pebbles etc. and then, filtered through a bag filter of 5 micron pore size. This is further filtered through a pre-filter having 2 micron filter size. Thus purified water undergoes reverse osmosis, and further passed through a mixed bed of anion-cation for deionisation. Again, the water is run through polisher and ultra violet treatment to convert into extra pure deionised water. Our water treatment