KAPL Search   GO

SWACHHA BHARAT ABHIYAN MESSAGE
Corporate Info
Manufacturing Facilities
Domestic Marketing
International Marketing
Company News
Doctor's Section
Products Ready Recknor
Feedback
Enquiries
Current Job Openings
Grievance Cell - Department of Pharmaceuticals
Client's Charter
Application form for employment
Vigilance
Tenders
Expression of Interest
MSME Procurements
RTI
Back Home


MANUFACTURING FACILITIES


MAJOR PRODUCT CATEGORY

KAPL offers a comprehensive range of life saving dosage forms:
(Pharma and Veterinary)

vPARENTERALS -Penicillins, Cephalosporins, Penams & General Products.

vNON–PARENTERAL ANTIBIOTICS & OTHERS.


PARENTERAL PRODUCTION – KEY FACILITIES


DRY POWDER PARENTERAL PLANT -Penicillins

A separate dedicated plant for ß-lactam [Penicillin] injectables like Benzyl Penicillin, Ampicillin Sodium, Benzathine Penicillin, Fortified Procaine Penicillin , Amoxycillin clevulanate Potassium Piperacillins, Tezabactum etc.





DRY POWDER PARENTERAL BLOCK

For manufacturing Cephalosporin injectables like Ceftriaxone, Cefotaxime, Cefoperazone + Sulbactam, ceftriaxone + Sulbactam etc.







SMALL VOLUME PARENTERAL [ SVP ]

Automated Manufacturing Lines of liquid injectables of 2 ml vials to 100 ml vials & ampoules of 1 ml to 5 ml.




ß-LACTAM INJECTABLE FACILITY – Salient Features:

vHigh tech, automated aseptic continuous production line capable of handling multi products, multi dosages to the highest accuracy and with least human intervention.

vVial washing, sterilization and cooling system: Gilowy, Germany – Capacity, 240 vials per minute.

vLine capacity – 80,000 vials per shift of 8 hours.

v Grade ISO-Class 5 p to sealing.

vSeparate classified area ISO-Class 7 for sealing process under ISO-class 5


vMezzanine at the top with all the services of utilities with separate AHUs.

vLoop system for de-mineralized water and water for injection.

vAutomatic filling and stoppering operation without manual handling.

vAutomatic Sticker Labeling Machine – 120 vials / minute.

#tab3#


CEPHALOSPORIN INJECTABLES MANUFACTURING FACILITY:

v Filling and stoppering automatic equipment from “Perry” USA.

vFilling, stoppering under ISO-class 5

vContinuous line, starting from filling to packing.

vCapacity 50,000 vials per shift of 8 hours.

SMALL VOLUME PARENTERALS:

v1,00,000 vials (2 ml) per shifts of 8 hours
v1,00,000 ampoules (2 ml to 3 ml) per shifts of 8 hours
vFrom washing to sealing entire operation under ISO Class-5 for both vials and Ampoules
vCGMP design / model for WFI plant with 500 litre / hour capacity.


NON-PARENTERAL KEY FACILITY:


TABLETS:


vFacility for Film coating, Enteric coating, Blister packing & Aluminium strip & Alu - Alu packing

v Machines / equipments for manufacturing tablets from 6 mm to 13 mm, with Capacity 10 lakhs per shift.

v Facility for manufacturing large tablets / bolus upto 6 gram weight.



CAPSULES:

vSeparate area for ß-lactam & Non-ß-lactam capsules dosage forms.

v10 lakh capsules per two shifts, size ‘2’ to size ‘0’.



LIQUID ORALS & DRY SYRUP, SACHETS & POWDERS:

vFacility for liquid syrup & suspension from 30 ml bottle to 5 litre container.
vFacility for dry syrup bottles 30 to 100 ml.
vFacility for powders in sachets, containers, 20 gm to 5 kg.

QUALITY CONTROL FACILITY:

vSeparate area for Chemical, Pharmacological, Microbiological, instrumental analysis.
vSeparate instrument room with sophisticated latest analytical instruments like HPLC, IR, Head space GC , Liquid particle counter , TOC , AAS etc.
vQualified & trained analyst & Microbiologist.


RM & PM STORE:


vSegregation of RM & PM as per CGMP requirements.

vReceipt / Issues / Approval / Rejection through Integrated Information System.

vCool room for storing antibiotics, capsules etc.

vClassified area for dispensing of RM for oral dosage form.

KEY QUALITY ASSURANCE SYSTEMS FOLLOWED

vIn house testing as per international specifications.
vArea / filters validations.
vAseptic filling process validation by broth fill trials. Protocol includes simulation trials for intrusions / interruptions.
vWater system validation [ DM & WFI ].
vIPQC.
vSelf inspection.
vTraining – GMP.
vMedical Health Monitoring.

vStability studies as per ICH guidelines for selected products.
vAnalytical method validation as per ICH guidelines.
vHold time for sterilized components – validation.
vEquipment cleaning validation – product change over etc.
vRoutine biological control [ Water, clean rooms and other manufacturing areas].
vEffective handling of Market complaints.

KAPL HAS BEEN MANUFACTURING PRODUCTS FOR REPUTED INDIAN AND MULTINATIONAL COMPANIES.



© 2003 Karnataka Antibiotics & Pharmaceuticals Limited. All rights reserved. Developed by SIFY Limited.