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SAAKH PHARMA (Pvt.) Ltd


An Overview of Manufacturing Facility Procedures and Quality Management System Plot No. C-7/ 1 N.W.I.Z., Port Bin Qasim Karachi. Factory is situated at Plot No. C-7/ 1 N.W.I.Z., Port Bin Qasim Karachi. Head office is situated at Phase VI

D.H.A.


General Information INTRODUCTION:

Saakh Pharma is Private Limited Company incooperated in 2014. Saakh Pharma’s Head office is situated in defense Phase VI. Saakh Pharma is an in corporate (Pvt.) Ltd. Company which was established in July 2014 for undertaking pharmaceutical business. It will produce synthetic and semi synthetic API’s. The objective of the organization is to produce API’s of BP and USP grade and to work for other Semi Synthetic penicillin and cephalosporin products in the future. It was old factory when the SAAKH Pharma takes over the position of company. Plant condition was not suitable for manufacturing of API’s. Total area is = 10369. Sqft.Total covered area is = 3300. Sqft. Following step were taken by the management to upgrade this factory for manufacturing of API’s as per cGMP and pharmacopeia requirements:

SAAKH PHARMA (Pvt.) Ltd. Finishing area in clean rooms:

Finishing area was upgraded as per cGMP requirements consisting of separate room for wet milling, drying, compaction, micronization and finished product quarantine areaOld wooden doors were replaced by new aluminium doors, HVAC system improved and separated as per requirements of clean rooms.

For safety point of view, all the lights were replaced with flame proof lights. The Epoxy coating was done on the floor to keep area clean for material and man flow.

Equipment of the finished area was polished and modified for safe operation

Separate controlled temperature finished products store built for API’s False ceiling and new ducting for HVAC in corporated. All the floor of

the finishing areas was epoxy coated and air curtains deployed on each entrance of finishing area.

SAAKH PHARMA (Pvt.) Ltd.

Raw Material Store

Separate store for Raw Material (6APA) constructed and controlled temperature maintained as per requirement. Dispensing booth will be arranged for dispensing of Raw Material.

Areas were designated for raw material quarantine, pass raw material and rejected raw material. Solvent storage shed constructed. Buffer area for incoming raw material was established. All the floor of the store were epoxy coated and air curtains deployed on every entrance of store


Manufacturing AreaMetals structure platforms on which vessels are mounted was in extremely bad and rusted position. All the sheets of metal structure replaced with new sheets and painted.

Reaction vessels were in extremely bad condition and their outer jackets were rusted and leaked. All the vessels jackets were rebuilt and hydraulic test completed for each one.

Reaction vessel R101 further modified for more batch size and equipped with more required services. Nitrogen sparger will be

Installed for better cooling of liquid nitrogen. Reaction vessel R 110 (crystallizer) also upgraded for more capacity and better utility services.

Centrifuges were in extremely bad condition they are modified and polished for better function and they are placed in separate cubical for safety point of view. Efficient exhaust system arranged for it.

Wet milling area segregated from the finishing area with efficient exhaust system and air course filters installed

SAAKH PHARMA (PVT.) LTD.

Machine Capacity Reactor No. 1 2500 LTR Reactor No. 2 1000 LTR Reactor No. 3 1000 LTR Reactor No. 4 680 LTR Reactor No. 5 450 LTR Reactor No. 6 340 LTR Reactor No. 7 225 LTR Centrifuge No. 1 150 KG Centrifuge No. 2 150 KGr Steam Boiler 1.5 Tons/Hour Fluid bed Dryer 30 KG/Hour Pulvalizer 40 KG/Hour Cooling Tower 300 GPM Chilling Tank 400 LTR Air Compressor 50KG Deminerlization Plant 600 LTR/Hour Water Softener 400 LTR/Hour Vacuum pump 40KG Granulator 40 KG/Hour Compactor 35 KG/ Hour

SAAKH PHARMA (Pvt.) Ltd Utility Department All the service lines present on the plant were rusted and

their insulation damaged. New services line of steam, chilled and cooling water installed from utility department to the plant reaction vessels.

New boiler on cheaper fuel and better efficiency installed. New chiller unit of -10 C is installed. Vacuum pump is overall

for better efficiency New HVAC with better efficiency installed

SAAKH PHARMA (PVT.) LTD Quality Control• Quality control laboratories are equipped with following new equipments.• HPLC• Karl Fischer• Spectometer• Electronic top loading balance• Muffle furnace• Magnetic Hot plate Stirrer• S.S electronic oven 25 ltr• Polarimeter• Ph Meter• Gas chromatograph• FTIR.• Stability chamber Quality control laboratory is fully refurnished


Manufacturing facilities

Semi synthetic penicillin SSp(s) A small Glass, apparatus plant for semi synthetic

cephalosporin grade.


List of Products SEMI SYNTHETIC PENICILLIN

Ampicillin Trihydrate Ampicillin Anhydrous Amoxcillin Trihydrate Cloxacillin Sodium

RAW MATERIALS FOR API’S

6 Amino Pencillinic Acid Para Hydroxy phenyl Glysine-dane Salt (Solid) Phenyl Glysine Ethyl Pottassium-dane Salt (Solid)

CEPHALOSPORIN Cefixime Cephradene Cefadroxil


Quality Policy

Best quality products with highest customer satisfaction as per cGMP guidelines.

SAAKH PHARMA PVT. LTD.

BEFORE RENOVATION

SAAKH PHARMA PVT. LTD.

SAAKH PHARMA PVT. LTD


After Renovation

Thank you!!!

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