MFR of Chloramphenicol EYE/EAR Drops
PURPOSE:
This Master Formula Record (MFR) is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.
SCOPE: This MFR is performed and is applied during the manufacturing of dosage form.
RESPONSIBILITY / ACCOUNTABILITY:
It is the responsibility of Manufacturing Chemist to follow and adhere to this MFR. The Production Manager, QC/QA Manager are accountable for the strict adherence to the master formula.
COPY ISSUED TO:
- Master Copy : Manager Quality Assurance
- Copy No. 1 : Production Manager
- Copy No. 2 : Manager Quality Control
- Copy No. 3 : Small Volume Parenteral Section
| PRODUCT NAME: Chloramphenicol EYE/EAR Drops | BATCH SIZE: 100 LTRS. |
| PRODUCT REFERENCE CODE: | UNIT SIZE: 10 ml |
| GENERIC NAME: N.A. | PACK SIZE: 576 X 10 ml. |
| DOSAGE FORM: OPTHALAMIC | STRENGTH: 0.5 % w/v |
| DEPARTMENT: STERILE PREPRATION | EXPIRY DATE: AFTER 30 MONTHS FROM THE DATE OF MANUFACTURING |
| COMPOSITION: | ||
| Chloramphenicol | I.P. | 0.5 % w/v |
| Phenyl Mercuric Nitrate (as preservative) | I.P | 0.001 % w/v |
| Sterile aqueous base | q.s. | |
EQUIPMENTS TO BE USED:
| SR. NO. | NAME OF EQUIPMENT | ASSEMBLING AS PER SOP NO. | CLEANING AS PER SOP NO. |
| 1 | Auto Clave with SS Transfer trolley | ||
| 2 | Multi Column Distillation Still | ||
| 3 | Distill Water Storage Tank | ||
| 4 | SS Batch Mixing Tank | ||
| 5 | SS Pressure Vessel – 100 Ltr. | ||
| 6 | SS Membrane Filteration Assembly (293 mm) | ||
| 7 | SS Filling Vessel – 100 Ltr. | ||
| 8 | Auto Liquid Vial Filling, Stoppering & Sealing Machine | ||
| 9 | Auto Vial Labelling Machine |
Equipments to be sterilized :
| SR.NO. | NAME OF EQUIPMENTS | STERLIZATION AS PER SOP NO. |
| 1 | S.S Membrane Filter Assembly- 293 MM | |
| 2 | S.S Filling vessel | |
| 3 | S.S Filling syringes | |
| 4 | Sterile dress of operator | |
| 5 | Pre Nitrogen Filling needles& POST- nitrogen filling needles | |
| 6 | Silicon tubes |
RAW MATERIALS:
| S.NO. | INGREDIENTS | STD | Theoretical Quantity Req. | Overages % | Total Quantity Used |
| 1 | CHLORAMPHENICOL | I.P | 0.500 | 5.0 | 0.525 KGS |
| 2. | BORIC ACID | I.P | 1.500 | – | 1.500 KGS |
| 3. | BORAX | I.P | 0.600 | – | 0.600 KGS |
| 4. | H.P.M.C | I.P | 0.075 | – | 0.075 KGS |
| 5. | PEG – 400 | I.P. | 5.000 | – | 5.000 KGS |
| 6. | PHENYL MERCURIC NITRATE | I.P. | 0.001 | – | 0.001 KGS |
| 7. | UREA | I.P. | 0.600 | – | 0.600 KGS |
PACKING MATERIALS:
| S.NO. | NAME OF THE MATERIAL | THEORETICAL QUANTITY REQ. | FOR RECORD | TOTAL QUANTITY USED |
| 1 | 10 ml PLASTIC VIALS WITH CAP & NOZZLE (PRE STERILIZED) | 10000.000 | – | 10000.000 NOS |
| 2 | ADHESIVE TAPE ROLL BROWN | 1.000 | – | 1.000 NOS |
| 3 | CELLO TAPE | 1.000 | – | 1.000 NOS |
| 4 | CORRUGATED BOX C-01A | 17.361 | – | 17.361 NOS |
| 5 | CHLORAMPHENICOL – 10 ml EYE DROPS STICKER LABEL | 10018 | 3.000 | 10021 NOS |
| 6 | CHLORAMPHENICOL – 10 ml EYE DROPS UNIT CARTONS | 10000.000 | 2.00 | 10002.000 NOS |
| 7 | CHLORAMPHENICOL – 10 ml EYE DROPS OUTER CARTONS | 416.667 | 2.000 | 418.667 NOS |
MANUFACTURING PROCESS:
Preparation of Solution:
Take in SS Batch Mixing Tank 300 Lt. of freshly prepared water for injection.
Add Boric Acid & Borax in distilled water and stir it properly.
Take Phenyl Mercuric Nitrate and dissolve it separately in hot distilled water and add to Batch Mixing Tank Stir it properly.
Dissolve Urea and stir properly.
Dissolve Chloramphenicol in water and add to it PEG-400 and put in BMT.
Dissolve Hydroxy Propyl Methyl Cellulose Solution and stir vigorously.
Adjust the pH to 7.2 (pH RANGE: 7.0 TO 7.5)
Make up the volume to 100.00 liter
Final pH = 7.2
Shift the solution from batch mixing tank to pressure vessel and do membrane filtration by using the appropriate
II) Filtration
Filtration is done with the membrane assembly by using the appropriate membrane & pre filter and post filter.
| Pre Filter | 1.5 µ | |
| B | Membrane Filter | 0.2 µ |
Aseptic Filing
After the process of washing, sterilization filtration filing of Aseptic filing is carried out in class 100 area under the
laminar flow. The machine adjustment is carried out for the appropriate vials as per SOP .
| Filling Station Adjustment | Yes/no | Yes | |
| B | Butyl Bung Station Adjustment | Yes/no | No |
| C | Sealing Station Adjustment | Yes/no | Yes |
IV) Volume variation is checked intermittently, volume prescribed 10.0 ml, and volume filled 10.1 ml, percentage variation 2%.
V) Labeling
Labeling of vials is done with the help of auto vials labeling machine as per sop.
VI) Packing
| Open Packing | Yes/no | Yes | Pack Size | 24 x 24 x 10 ml | |
| 2 | Blister Packing | Yes/no | No | Pack Size | NA |
VII) Yield
| Percentage Yield | – | 100 ± 2% | |
| 2 | Theoretical Yield | – | 10000 x 10 ml |
| 3 | Expected Practical Yield | – | 10000 x 10 ml ± 2% |
MANUFACTURING SPECIFICATION:
Average fill of each vial is 10 ml.
Weight variation limit allowed in each filled vial is 10.0 ml to 10.1 ml.
Use accurate quantity of water to make up the final volume of the solution.
Filter the completely charged batch solution using membrane Filtration apparatus using appropriate Membrane filter, pre membrane filter.
Transfer the solution from mixing tank to pressure tank after complete charging of batch.
Temperature should be kept at 25°c for entire operation, relative humidity should be kept at 40% for Entire operation.
Packing Details :
Pack the filled vials in unit carton
Pack such 24 unit cartoons in each outer carton.
Pack the 24 outer cartons in specified corrugated box to give pack size of 24 x 24 x 10 ml.
Seal the corrugated box with adhesive tape and label it properly by affixing the specified label
Also Read :– MFR of Pantoprazole Sodium Sesquihydrate Injection
IN-PROCESS CONTROL:-
The following in process controls should be moistened during the processing
Check raw material used for manufacturing purpose are all approved and have ‘released’ labels fixed on it.
All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy
is noticed, it should be immediately brought to the notice of Production Manager and QC/QA Manager.
Physical characteristics of Raw material like colour, odour and consistency are checked before compounding.
Final volume should be made as per Standard Operating Procedure.
pH of the bulk should be checked and it should be with in specified limits.
Bulk sample should be sent for analysis to Q.C. Department before starting the filling and sealing stage.
Intermittently filled volume should be checked at 30 minutes interval by the Manufacturing Chemist and record for the same should be kept in Batch Manufacturing Record.
The net volume should be checked for all the filling nozzles and in no case net volume should be less than volume claimed on the label. (Limit for volume variation: volume claimed + 2%
Visual inspection of filled and sealed vials should be done as per SOP NO. SOP/SV/016/GN/II and the record of the same should be kept in B.M.R.
The labels and cartons should be checked thoroughly for proper batch coding.
Intimation should be sent to Q.C. Department for finished product sampling and testing.
After the completion of labeling and packaging the coded labels and cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the B.M.R.
It will be ensure that filling or packing equipment has been properly cleaned.
Filling or packaging of next product should not commence until the ‘Line Clearance’ has been given by the IPQA.
Carry out bubble test for checking the integrity of membrane filter as per SOP.