AMOXYCILLIN CLAVULANATE  FOR INJECTION

AMOXYCILLIN CLAVULANATE FOR INJECTION

AMOXYCILLIN CLAVULANATE  FOR INJECTION

PRODUCT INTRODUCTION

AMOXYCILLIN- CLAVULANATE FOR INJECTION  is a penicillin-type of antibiotic that helps your body fight infections caused by bacteria. It is used to treat infections of the lungs (e.g., pneumonia), ear, nasal sinus, urinary tract, skin, and soft tissue. It will not work for viral infections such as the common cold.

Amoxycillin- Clavulanate for Injection is generally administered by a healthcare professional and should not be self-administered. Depending on the severity of your underlying illness, your doctor will decide the precise dose and schedule as per which this injection is to be given. It is strictly advised to be used as per the doctor’s prescription.

Common side effects of this medicine include nausea, vomiting, and diarrhea. Additionally, you may notice some injection site reactions like pain, swelling, or redness. Please consult your doctor if these do not get better or persist for a longer duration of time. In cases of patients with severe liver or kidney disease, consult your doctor before you start the treatment.

Before using it, you should tell your doctor if you are allergic to any antibiotics or have any kidney or liver problems. Your doctor may change the dose or prescribe a different medicine. This medicine is generally regarded as safe to use during pregnancy and breastfeeding if used under a doctor’s supervision.

Amoxycillin

Generic Name: Amoxycillin- Clavulanate for Injection

Strength:600 MG

Lot size:70500 units

Average Filled Weight:666 mg/vial

Label Claim: Each vial contains:

Amoxycillin Sodium & Clavulanate Potassium USP

Equivalent  ___________ 600 mg

Shelf Life: 2 Years

Dosage Form: Dry powder for Injection  ( For IM / IV Use ).

OPERATING PARAMETERS:Room Temperature : 23 + 2°C  , Relative Humidity: 25 + 5 %.

MANUFACTURING FORMULA

S.NoIngredientStandard QuantityCompensation Factor  Required Quantity
01 Amoxycillin sodium & Clavulanate Potassium USP42.30 KG11.00%46.953 KG*

* Exact Required Quantity depends upon Assay and Moisture / LOD content of Raw Materials.

Calculations:

Required Quantity of Amoxycillin sodium& Clavulanate Potassium

=   Lot Size in No. X 0.60 gm X 10  / Assay on an anhydrous basis X (100 – Moisture)

PACKING MATERIALS

ItemSpecification
 Vials10 ml Vial White Type I
Seal20mm F/O -Black[CODE-C]
PlugsRubber Plugs 20mm Bromo Butyl

GMP CHECKLIST

  1. The area is free from unwanted material as well as the material from the last batch/ product.
  2. All equipment and containers used in processing in this batch are cleaned to the required standard.
  3. The wash water analysis report is available in case of product change over.
  4. The product is labeled at all stages with all details such as the name of the product, Lot no., and Mfg. date, Exp. date.
  5. All the instructions of manufacturing procedure are strictly followed and any deviation is made only after consultation of manager Q.A and recorded.
  6. The temperature and relative humidity of the manufacturing area is 23 + 2°C & 20% – 30% respectively and these parameters are checked and recorded every 1 hour by operation and 2 hours by QA during the process.
  7. A sterile dress is worn during the manufacturing process.
  8. All the critical parameters are to be recorded as per BMR.

PRECAUTIONS:

  • All parts in contact with the product must be of inert material.
  • Wear proper dress and accessories while handling raw materials.
  • Keep the sample collected at each stage separately till the batch manufacturing is Completed.
  • Check autoclave load indicators (chemical) of sterile loads before using every individual
  • Check all print out of equipment.

 EQUIPMENT CHECKLIST

S.No.EquipmentPrevious product
1SS Hopper
2Linner vial machine
3Vial filling and stoppering machine
4Vial sealing machine
5SS Treys
6Sterilization and depyrogenation Tunnel
7Autoclave
8Electronic balance

DISPENSING PROCESS

  • Manufacturing chemist shall punch material requisition slip in ERP and take a printout Signed and shall give it to store in charge .
  • Store In charge dispenses the approved raw material in the presence of the production person and IPQA person.
  • IPQA person shall tally the weighed quantity with requisition slips and shall sign on dispensing sheet and BMR.
  • The storekeeper shall fill the issued quantity and analytical control number on BMR and sign it  & transfer the dispensing raw material to the filling section.
  • Issue the required quantity of primary packing material from the store.

WASHING AND STERILIZATION PROCESS OF VIALS AND RUBBER PLUGS

  • Remove approved empty vials from the boxes in De-cartoning area and load the vials on the conveyor of vial washing machine .
  • Wash the vials in automatic liner vial washing machine as per validation cycle and SOP .
  • Checking of washed vials done by production and IPQA In charge at frequent interval .
  • After washing vials are automatically transferred in sterilization and depyrogenation tunnel for sterilization and depyrogenation . Check pressure of different zone of tunnel, and sterilization temperature and conveyor speed of tunnel at every hours . After sterilization vials are automatically transferred in filling area .
  • If rubber stoppers are not Ready for use then wash and sterilized the rubber plug in bung processor with HPW and transferred the washed and sterilized rubber plug to the filling area.

FILLING AND SEALING

  • Maintain the temperature and relative humidity of the filling area before doing filling process and recorded at frequent interval .
  • Take the Blended raw materials under sterile condition .
  • Fill the blended sterile powder in the hopper  and starts filing operation .
  • Adjust the fill weight of the powder ( Range – 666 mg ± 2% )
  • After filling  rubber plugs are automatically bunged  on filled vial by automatic plugging machine.
  • Seal the vials with the help of automatic vial sealing machine.
  • Check the weight variation , Temperature , RH % , Pressure differential and sealing of vials after every hour .

VISUAL INSPECTION:

  • Check the filled vials for the presence of any foreign partials.
  • Keep the good vials separate with a label containing the product name, lot No., Mfg.Date, Exp.Date.
  • Keep the rejected vials in separate tray labels of the type of rejection.
  • Transfer the good vials to the Quarantine Section.
  • IPQA In-charge does the random sampling of products for final analysis by QC.

LABELLING  AND PACKING INSTRUCTION 

  • The packing area is free from unwanted material as well as material from the last batch/product.
  • The line equipment and containers are properly identified.
  • Care is taken to avoid mix up during all stages of packing.

PROCEDURE

  • Take the dispense packing material that is labeled, carton, literature, inner carton box and outer carton box etc.
  • Take the vials from quarantine area for labeling, paste the printed labels on the vials with the help of labeling machine.
  • Check the initial coding of labels for batch No. Mfg.Date, Exp.Date and MRP.
  • Check the labeled vial and packing carton with packing insert.
  • Packing supervisor and IPQA In charge shall randomly inspect the quality of labeling and coding every two hours.
  • Pack the final product in corrugated boxes.
  • After the QA approval transfer the finish product to store .

STANDARDS  AND IN-PROCESS  CHECK

S.NoParametersStandardsFrequencyPerson Responsible
1Colour of reconstituted solutionClear Colourless solutionAt the time of reconstitutionMfg. Chemist

IPQA Incharge

2Fill Weight Check666 mg ±2%2 HoursMfg. Chemist

IPQA Incharge

3Cleanliness of filled vialShould be clean2 HoursMfg. Chemist

IPQA Incharge

4Seal Check20mm F/O Black2 HoursMfg. Chemist

IPQA Incharge

5Mould DefectAll the Vials should pass2 HoursMfg. Chemist

IPQA Incharge

6Overprinting  on Labels  and

other Packing material.

At the time of packing2 HoursMfg. Chemist

IPQA Incharge

7pH8.0 – 10.0At the time of finished product   testingQC incharge
8AssayBetween 90% to 110% of label claimAt the time of finished product   testingQC incharge
9Water/LOD/MoistureNMT 3.5 %w/wAt the time of finished product   testingQC in-charge

YIELDS

S.NoProcessTheoreticalPermissible
1Bulk100 %98 – 99.5%
2Filling99.0%97 – 99.0%
3After visual inspection and packing97%96 – 97%

EQUIPMENT, MACHINERY, AND ACCESSORIES

S.No.EquipmentMakePurpose
1.Weighing BalanceCitizenWeight Adjustment
2.Vial Washing MachineLaxmi PharmaWashing of Vials
3.Sterilizing TunnelFabtecSterilization & Depyrogenation of Washed Vials
4.AutoclaveMetal ChemSterilization of Dresses , filling item and accessories
5.Filling  and sealing MachineFabtecFilling of powder into Vials
6.External Vial Washing machineN.K. Pharma ProductsExternal washing of vial
7.Visual Inspection TablePragathiVisual inspection
8.Labeling MachineAmbicaVial Labeling

ANALYSIS

  • Raw material analyzed and released by Q.C for filling.
  • Filled Vials are drawn online for analysis by IPQA.
  • All the analytical tests are performed by QC Chemist from Quality Control. The batch is released after 14 days.

CONTROL SAMPLES

10 labeled and duly packed Vials are collected online by IPQA In charge during packing and sent to QC for storage in the control sample room.

WASTAGE / REJECTION DISPOSAL

Control samples are destroyed 3 months after the expiry of the batch as per standard operating procedure. Destruction records are to be maintained. Filled rejected Vials are first inactivated by using suitable chemicals and then destroyed by crushing as per the standard operating procedure. Printed packing material is destroyed by shredding it into small pieces.

DOCUMENTATION CHECK

  • All the documents are Checked by the department head or concerned person and duly signed by authorized Q.A. personnel.
  • Batch records are to be preserved for 5 years after manufacturing in the record room.

TRANSFER

  • Packed finished goods are transferred to FGS  after proper entry in ERP. Dispatched after finished good inspection by IPQA and release by QA HEAD.
  • Distribution records are maintained at finished goods stores.

TECHNICAL DIRECTION

Generic name: Amoxycillin  and Potassium Clavulanate for Injection

Party Name:

Claim: Each vial  contains:

Sterile  Amoxycillin Sodium to  Amoxycillin……………………………………… 500 mg

Sterile   Potassium Clavulanateeq. to  Clavulanic acid ……………………….. 100mg

Description of Product:

White to pale yellow/cream colored crystalline powder filled in glass vials and sealed with rubber plug and flip-off aluminum seal.

S. No.ComponentBrief DescriptionQty./Super

Master

Packaging Instructions
1.Glass Vial 10 ml10 ml type- I Vial with 20 mm Neck, Neutral glass240 No.Fill Sterile powder as per required weight aseptically.
2.Rubber plug20 mm Bromo Butyl240 No.Plug the vial using a sterile rubber plug aseptically.
3. Flip-off seal

( Black )

20mm standard virgin flip-off aluminum seal with a black color plastic flip.240 No.Seal the vial properly using flip-off aluminum seal.
4. Label

 

Sticker Label for vial printed as per the approved color, text & design on GSM 80 ± 10%.

Size :  70 x 28 mm ± 1 mm

240 No.Paste one label on each vial duly coded with batch No. Exp. date & Mfg. Date.
5.Unit carton

 

Unit carton made up of 300 GSM ± 10% laminated art card, printed as per approved text, color and design.

Size :  34 x 34 x 62 mm ± 1 mm

240 No.Put 1 vial in each unit carton duly coded with all batch details.
6.LiteratureAs per party artwork240 No.Put 1 in each unit carton.
7.Shrink pack

 

Shrink pack made from 9-inch polythene roll24 Nos.

 

Pack 10 unit cartons in each shrink pack.
8.Master Corrugated box

 

Corrugated box made up of 3 ply as per approved design, color, and text,

Size:  220x 180 x 138 mm ± 3mm

  04 Nos.Put 6 shrink packs in each master corrugated box.
9.Super Master corrugated box (Shipper Master )Corrugated box made up of  5 ply as per approved design, color, and text,

Size – 370 x 237 x 290 mm  ± 3mm

01 No.Put 04 master Corrugated boxes in each super master corrugated box.
10. BOPP tape

Brown plain

48 mm  ±1 mm wide self-adhesive BOPP tape plain.Qs.Close the corrugated box flaps and seal them using BOPP tape

BENEFITS OF AMOXYCILLIN- CLAVULANATE FOR INJECTION

In Treatment of Bacterial infections

Amoxycillin- Clavulanate for Injection contains two different medicines, Amoxycillin and Clavulanic Acid, that work together to kill the bacteria that cause infections. Amoxycillin works by stopping the growth of bacteria. Clavulanic Acid reduces resistance and enhances the activity of Amoxycillin against bacteria.

This combination medicine can be used to treat many different bacterial infections such as ear, sinus, throat, lung, urinary tract, skin, teeth, joints, and bones. It usually makes you feel better within a few days, but you should continue taking it as prescribed even when you feel better to make sure that all bacteria are killed and do not become resistant.


SIDE EFFECTS OF AMOXYCILLIN- CLAVULANATE POWDER FOR INJECTION

Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them

Common side effects of AMOXYCILLIN- CLAVULANATE FOR INJECTION

  • Vomiting
  • Nausea
  • Diarrhea

HOW AMOXYCILLIN- CLAVULANATE POWDER FOR INJECTION WORKS

Amoxycillin- Clavulanate for Injection is a combination of two medicines: Amoxycillin and Clavulanic Acid. Amoxycillin is an antibiotic. It works by preventing the formation of the bacterial protective covering which is essential for the survival of bacteria. Clavulanic Acid is a beta-lactamase inhibitor that reduces resistance and enhances the activity of Amoxycillin against bacteria.
MASTER FORMULAS