Simpex Admin

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<p>
	The manufacturing environment is critical for product quality. The environmental features include following:</p>
<h3>
	1- Lighting:</h3>
<p>
	In Simpex pharma adequate lighting is provided in all area.</p>
<h3>
	2- Nature of construction and finishes:</h3>
<p>
	The building is constructed with Reinforced Cement Concrete Structure. All the walls are built with brick work having smooth plastered finish. The interfaces of walls, floor and equipment are coved to facilitate cleaning. Partitions and doors are made up of steel with powder coating and glasses. In some areas the partitions are of brick work and glass windows.</p>
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	Internal walls: Walls are painted with polyurethane paint which is water washable.</p>
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	Ceiling: Ceiling in processing areas is painted with polyurethane paint. Ceiling in all other area is painted with plastic emulsion paint.</p>
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	Drainages: Processing areas are provided with double Trap SS 304 drain. Change rooms have normal sanitary drainage system.</p>
<h3>
	3- Ventilation, air filtration, air heating and cooling:</h3>
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	The Heat, Ventilation and Air Conditioning system is controlled through Honeywell Comfort Point Open Building Management System. The system provides convenient, single-point monitoring and control of HVAC system.</p>
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	(b) Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature is provided when appropriate for the manufacture, processing, packing, or holding of a drug product.</p>
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	(c) Air filtration systems, including prefilters and particulate matter air filters, is used when appropriate on air supplies to production areas. If air is recirculated to production areas, a measure is taken to control recirculation of dust from production. In areas where air contamination occurs during production, there is adequate exhaust systems or other systems adequate to control contaminants.</p>
<h3>
	4-Plumbing:</h3>
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	Potable water is supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations set forth in 40 CFR part 141. Water not meeting such standards shall not be permitted in the potable water system.</p>
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	Drains is of adequate size and, where connected directly to a sewer, is provided with an air break or other mechanical device to prevent back-siphonage.</p>
<h3>
	5- SANITATION:</h3>
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	Cleaning & sanitization procedures for manufacturing areas and equipment:</p>
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	<strong>a) Procedures and specifications </strong><br />
	The manufacturing areas, corridors and change rooms are cleaned and sanitized using the cleaning and disinfecting agents certified by Quality Assurance. Floors of manufacturing and general area cleaned with 2.5 % Dettol and 2.0% savlon solution on alternative basis. The cleaning and sanitizing procedures detail the methodology of cleaning and sanitizing procedures and the frequency of cleaning and sanitizing.</p>
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	<strong>b) Rotation of cleaning agent.</strong><br />
	The sanitizing agents are rotated on two days basis for use. These sanitizing agents are rotated to avoid the incidents of developing resistant strains of contaminants</p>
<h3>
	6-Maintenance:</h3>
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	The site, water systems and Air Handling Units are maintained in good working condition to ensure that that they do not present any hazard to the quality of product.</p>
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	The Preventive Maintenance is carried out as per the predefined frequency using duly approved written procedures. The preventive maintenance program comprises of Monthly, Quarterly/Six monthly/ Yearly and overhauling checks including inspection of lubrication ports, all drives, sensing and recording systems, wear & tear of moving parts.</p>

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