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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 area
Old 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.

 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 Area
Metals 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
 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

 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.

SAAKH PHARMA(Pvt.) Ltd.
 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
After Renovation

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