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VIALS (Dry Powder Injection/ Liquid Vials / Lyophilized Vials)
Compact line for Dry Powder Injection, Liquid in vials and lyophilized products in Vials, with aseptic fill / finish technology.
Area Classification
»
Vials washing & Sterilization Area : Grade D
»
Manufacturing Area : Grade C
»
Filling & Stoppering Area : Grade A/B
»
Cap Sealing Area : Grade A/C
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Compact line for liquid filling in Vials and
Lyophilized products in Vials with aseptic fill / finish technology.
 
 
Production Capacity Per Annum
 
»
Vial (Dry Powder Injection) : 15 million
 
»
Vial (Lyophilized) : 2 ml. – 3 million
      : 10 ml. –1 million
 
 
 
AMPOULES
Compact line for manufacturing & filling of terminally sterilized / aseptically processed product in ampoules.
Area Classification
»
Ampoule Washing & Sterilization Area : Grade D
»
Manufacturing Area  
Aseptically processed Products
: Grade C
»
Ampoule Filling & Sealing Area  
Aseptically processed Products
: Grade A/B
»
Filteration Area : Grade A/B
 
Production Capacity Per Annum
Ampoules : 36 millions
Highlights
One compact filling lines for Ampoules aseptically / terminally sterilized and processed products.
 
 
Eye / Ear / Nasal Drops

Compact line for manufacturing of Eye / Ear / Nasal Drops in ready for use closed and open Nozzle Dropper.

Area Classification  
»
Manufacturing Area : Grade C
»
Filtration Area : Grade A/B
»
Filling & Stoppering Area : Grade A/B
»
Cap Sealing Area : Grade A/B
Production Capacity Per Annum
Eye/Ear/Nasal Drops : 10.8 million
 
LYOPHILIZED STERILE PRODUCTS
Compact line for manufacturing of lyophilized sterile powder.
Area Classification  
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Manufacturing Area : Grade C
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Filtration Area : Grade A/B
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Lyo. Loading & Unloading Area : Grade A/B
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Primary Packing Area : Grade A/B
Production Capacity Per Months
Sterile Lyophilized Powder : 800 kg/ Month
 
QUALITY CONTROL
COMPLETE SUPPORT FOR :
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Analysis of Raw materials, Packing materials, In Process, Finished product, Microbiological etc.
» Control sample storage
»
Stability and Documentation
»
Environmental Monitoring
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QC has separate sterility testing room and micro testing room with dedicated PALs
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Dedicated stability chambers for different Temperature / humidity conditions
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Environmental monitoring and sterilitytesting / media fill
 
GMP
COMPLETE SUPPORT FOR :
All the three lines are independent of each other starting from issue of primary packing materials i.e. vials, ampoules, Ophthalmic etc. to the exit of finished goods in each line. These lines are equipped with dedicated AHU’s, Pre and Post Autoclaves, washing machines, depyrogination tunnel, filling and sealing machines, labeling and packaging machines.
 
SPECIAL FEATURES OF THE FACILITY
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Box in Box type model with Unidirectional layout and segregated man material movements
» Man entry in core area through secondary change facility
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Material entry through double door interlocking hatch
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Classified areas are erected with prefabricated modular partitions and filling areas have SS panels
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All classified areas have terminal HEPA filters of H14 Grade
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Joint less Epoxy flooring in all critical areas
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Electronic Access control for core areas
»
Dedicated areas for sampling and dispensing of RM with segregated MAL & PAL
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Complete facility has 100 % power backup
»
HVAC of all CLASSB FILLING AREAS + all critical LAFS / Incubators ARE CONNECTED TO UPS
 
QUALITY POLICY
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The company is committed to develop, sustain high quality in manufacturing of drug formulation in order to meet the customer satisfaction.
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This will be achieved by application of sound Quality Management System and adopting current Good Manufacturing Practices and comply all regulatory requirements.
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While doing so we shall keep in mind safety of our employees, all work processes as well as our natural environment.
»
The company shall manufacture products of high quality, which shall be safe for human consumption and shall have consistent properties of dosage form.
»
We consider our human resources as one of the biggest asset. Our qualified and trained staff is provided constant training to upgrade their knowledge and stay conversant with state of art technology.
»
We value motivation amongst our personnel as an important factor to make them more competent and quality conscious.
»
The quality assurance of its products is the obligation of the company and all the departments of the company share it by keeping vigil while purchasing, maintaining, manufacturing, testing, distribution and marketing of its products.
»
Our regular validation of process, test method, water & environment, as well as periodic calibration of all the instruments provides the guarantee of our product output of consistent top quality formulation.
»
The company shall make available all the requisite measures and resources to achieve the above goals.
 
(Ref. Quality Manual)
 
ENVIRONMENT, HEALTH & SAFETY POLICY
We are committed to manufacture and supply injectable preparations in Ampoules, Vials ( Dry powder Injection, liquids vials, &lyophilized vials),with due respect to environment, health & safety aspects.
We shall comply with the relevant Environment, Health, Safety legislation and other requirement
 
 
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