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
Thanks, what is the cost of a small manufacturing plant?
It give me very important knowledge about the production process of eye ear and Nasal drop and ointment. I leave in Ethiopia I have more than 5 year expriance in industrial pharmacy as a production pharmacist in tablet syru ampule capsule ampule large volume parentrals like dextrose normal saline( DNS )Normal saline (NS) ringer machete( Rl) in small volume parentral like chloroquine smile diclofeback ampule skin cream Whitefield dermalar cream sulfer methyl salcilate.
I have also worked as pharmasitical microbial analist for micribial limit test sterility test indotoxine test for pyrogen using mandatory animal test using rabit and also using LAL test for rawmaterial for finished product and for manufacturing premises .I have also done as phisicemical analist both instrumental method Hplc mass spectrometr IR etc and also clerical method of analysis like tiatration precipitation etc.I have a strong interest and expriance of pharmaceuticals unit operation machine like capsuke filing machine blisteting machine syrup filing and caping machine assembling dismantling and maintaining .and. making a modefic wet anf mixer milleretc.now I am interested to open eye ear and Nasal drop manufacturing because thire is no such line in Ethiopia. I have goten manufacturing place could you send me the area needed for raw material store dispensing raw material room dry mixing wet mixing filteration stralization eye ear and Nasal drop filing caping and silling room.heat aier ventilation sistem (HAVC) water treatment line for demiwater and parmaceutical gread water and steam generation machine and other machine that you think esential thire coast thire delivery time.and the coast of eye ear and nazal drop active pharmaceuticals ingridient like ceprofloxaciline gentamicine dexamitasone hidrocortidon clotrimazoke neomicine clotrimazole ketoconazole stropine xylometazoline timolol philocarphine troicamaide acyclovir preservative benzalconium chloride third sampling and deliverry date legal transactions risck free mechanism
I need to make a project for producing nasal spray drops and I need to know what’s the machines needed.