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FORMULATION

FORMULATIONS

At Synmex pharma, we consider formulations as a data-driven science and follow a systematized approach of production. Our efficient product development algorithm involves defining target formulation profiles after understanding the needs of the clients. Our best-in-class manufacturing unit is located in Central India within the vicinity of dry port. Our plant is WHO-GMP and ISO: 9001-2008 certified while all our production activities are as per CGMP norms.

Tablets & Capsules

  • This section has five epoxy-coated fabrication areas and 12 compressions / filling cubicals. Each one is classified, pressure differential and works at 22 +/- 2 degrees. It has the following facilities .
  • High-speed sophisticated equipment including GIGA and MEGA press tablets compression (75 to 35 stations double rotary, PC monitored).
  • The cubical is designed with separate AHU/Dust extraction/pressure differential system to meet the environment control norms.
  • Capsule department has high speed filling machine which consists of capsule hopper magazine, raceway & push plate, rectifier block loading rings & rotary table for powder filling.
  • Regular in-process tests during the production operation.
  • Strict adherence to SOP norms.
  • Proper documentation and flow sheets of the various production operations & all the production records.
  • Uni-direction flow of man-power and material.

Injections

The facility is divided into small divisions of washing to packing where the flow of man- power and material is in uni-direction. The facility includes –

  • Injectable lines (4 lines/3 tunnels) each with separate AHU systems
  • Washing machines: These are Ampoule Washing Machine (with ultrasonic system), rotary vial washing machine: ARVW – 120, Auto clave (HPHV system), four-head ampoule filling & sealing machine, automatic liquid vial filling machine with rubber bunging with aluminium cap sealing arrangement, machine for visual checking, Ampoule labelling machine & vial labelling machine.
  • Machines for dry powder injections: For this we have vial washing machine with siliconization tank, rubber bung machine with siliconization tank, dry heat sterilizer, autoclaves, powder vial filling, rubber stopper, cap sealing machine ( AHPE – 120), vial labelling machine.
  • Tunnel System: We use the most standardized system for the sterilization of the products by means of dry heat. One end of the tunnel is attached with washing area while the other end is attached with sterile filling area by means of a diaphragm.

Liquid Oral

  • We take utmost care against cross-contamination in liquid department through a separate air handling system. It is a classified area with a single line high speed machine. We have the following systems in place.
  • The area is furnished with flush type fall ceiling and lighting fixtures, flooring with epoxy jointing.
  • DM water system is through SS316L piping loop, which is internally Electro polishes and externally buffed to meet WHO-GMP standards.
  • Regular documentation and implementation of in-process quality control checks.
  • Uni-direction flow of man-power and material.

Ointments

  • The ointment facility is a classified area with separate AHU system. The flow of manpower and material is in uni-direction. We have -Automatic tube filling, sealing & crimping machine from square pharma.
  • Batch fabrication equipment for 500 kg batch size.
  • Facility for filling and packing in both lami-tubes and aluminium tubes; containers (plastic and metal) and inhalers.
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