Ear and Ear are most sensitive parts of our body. A minor mistake can become serious problem, so everyone should be careful during manufacturing and use.
Here we are going to discuss some important inputs regarding manufacturing of eye/ear and nasal preparations. Read documents and licenses required to start manufacturing unit here
Strict aseptic and sterile conditions is required in manufacturing of these preparations.
Technical Staff:
- Manufacturing Chemist
- Analytical Chemist
- Quality Assurance Manager
- Supervisors
Non Technical Staff:
- Machine Operators
- Helpers
Types of Eye/Ear/Nasal Preparations
- Single Dose Preparations
- Multiple Dose Preparations
Dosage form of Eye/Ear/Nasal Preparations:
- Drops
- Lotions
- Ointments
- Washes
Section Required:
- Warehouse
- Washing Section
- General Production Section
- Weighing, mixing and Transfer Section
- Sterilization Section
- Filling Section
- Capping and Sealing Section
- Labeling and Packaging Section
Equipments and Machinery Required for Eye/Ear/Nasal Drops:
- Wax mixing vessel
- mixing vessel / storage vessel
- Transfer pumps
- Vacuum pumps
- Autoclav
- Dry Heat Sterilization equipments
- Eye/Ear/Nasal Drop Filling Machine
- Capping and Sealing Machine
Procedure for manufacturing of Eye/Ear/Nasal Drops:
- Dispensing of raw material (Active ingredient, Excipients, preservatives, vehicle etc)
- Accurately Weigh and measured quantity should be dispensed
- Sterilized Plastic or glass containers are used for filling drops
- Prepare a solution of vehicle with adding active ingredients, preservatives, excipients and other substances
- Make-up volume by adding more vehicles
- Filter this solution for removing any foreign and suspended particle
- Clarified solution is filled into final container
- Next step is sterilization. Sterilization involves autoclaving, Filtration (membrane filter 0.22 µg pore size into sterile containers using strict aseptic technique) and dry heat sterilization (For non aqueous preparations)
- Cover the container with breakable seal and Seal the container
- Now sealed container go for labeling and packaging
Equipments and Machinery Required for Ointments:
- Wax mixing vessel
- mixing vessel / storage vessel
- Transfer pumps
- Vacuum pumps
- Semi Automatic Tube Filling Sealing & Coding Machine
- Automatic Tube Filling Sealing & Coding Machine
- Sealing Machine
- Labeling and Packaging Machine
Procedure for Manufacturing of Eye Ointments:
- Dispensing of all ingredients included active ingredients, Liquid Paraffin etc
- Small sterile collapsible tubes is used for filling of eye ointments
- Prepare a sterile ointment base
- Finely powdered active ingredient / sterilized concentrated solution incorporated into sterile ointment base
- Fill the ointment into sterile tube
- Seal, label and send for packaging
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