Research & Devepment


One of the most important sections of Shafa Company is Research and Development Unit . This unit has been established in 1999 aiming to facilitate the incorporation of the latest international approved technologies into our fermentation and synthetic production plants. This unit ben¬efits from different experts in the fields of microbi¬ology, biotechnology, chemical engineering, phar¬maceutical, laboratory sciences, mechanical and electronic engineering. Today, relying on its technologies produces and presents derivatives of Erythromycin such as Azithromycin, Clarithromycin, Erythromycin Base, Erythromycin EthylSuccinate and Erythromycin Thiocyanate for general and veterinary use. This company also develops and markets industrial Erythromycin Thiocyanate through Biotechnological process. 
Relying on its skilled experts, R&D Unit can generate technical knowledge in dif¬ferent production processes such as biotechnological and synthetic pro-cesses in conformity with GMP and FDA. 
The manager of Shafa´s. R&D unit welcomes any suggestion for joint projects in production, contract manufacturing and research fields. 
 


Our analytical devices are as follows:


•HPLC (equipped with detectors of UV, photo Diode Array, Electro Chemical, refractive Index and Fluorescence)
•GC furnished with (TC,FI,EC) detectors and trioprocessor, etc.
•FT_IR
•UV_VIS Spectrophotometer, 
•Polari meter
•Atomic Absorption
•Spectrometer
•TLC Scanner
•GC (equipped with TC, FI and EC detectors and trio processor, etc.)

 


Other laboratory equipment :


•Light Microscope with camera for research purposes
•Refrigeration Shaker incubator 
•Freezers (– 80 °c)
•Laboratory Fermentors
•Different kinds of Incubators
•Thermostatic Laboratory Viscometers in various volumes
•Oven
•Jacketed Reactors with mechanical agitation mixer 
•Cool & hot circulator bath water 
•Laboratory F.B.D (Fluidized Bed Dryer)
 


Contract Manufacturing


Contract manufacturing section is active in production of Recombinant drugs in its outsourcing service; Gamma-Interferon (γ Interferon) and Erythropoietin (EPO) are produced in Shafa Biopharmaceutical unit. In addition in Shafa small scale production unit, according to the demands of the customers, another API, namely Alprazolam, has been produced. 

Fermentation Unit: It contains 20, 50, 75, 100, 750 liters Fermentors, industrial shakers, vessels, etc. and Purification Unit including Microfiltration and Nanofilttration systems (MF& NF), liquid liquid centrifuge extractors, vessels and various reactors. 

Synthesis Unit: comprising 5, 50, 100 and 200 liters Glass Lined reactors equipped with reflection and distillation systems, stainless steel reactors with reflection and distillation systems, low pressure operator, rotary vacuum evaporator filter press, cartridge filter, basket centrifuges, under pressure hydrogenation reactors, dryer systems of VTD (Vacuum Tray Dryer), RVD (Rotary Vacuum Dryer), FBD(Fluidized Bed Dryer) with capability of testing, controlling and implementing different reactions. 

Shafa´s analytical laboratory, as a state of art center is capable to analyze different pharmaceuticals,APIs and raw materials. It has also extensive experiences in documentation, validating, method development, and providing DMF (Drug Master File) under GLP requirements which are compatible with required process.


CONTRACT MANUFACTURING EQUIPMENT IN 
Shafa's Pilot Plant


1

Apparatus Disc Manual Desludging
Applications - RNA Clarification or other biochemical applications in biochemistry industry.
- Separation of water from animal and plant oils.
- Clarification of drinks, fruit juices, milk and antibiotics
- Separation of liquids which are different from the view point of density.
 
Output 
Capacity
100-1500 L/h ( in case of RNA the output capacity of 100 L/h is accessible)
Discs Rotation 
Speed
6930 r / min
Material Stainless steel 316


2

Apparatus Fine Crusher
Applications - Pharmaceutical raw martial mill with the mean viscosity & hardness
- Chemical raw martial mill with the mean viscosity & hardness
- Foodstuff mill with the mean viscosity & hardness
 
Production 
Capacity
10-30 Kg/h
Mesh ( 50 -70 µm ) 200-300

3

Apparatus Fluid Bed Dryer
Applications - Pharmaceutical , chemical & nutritious powder or granule dryer
- Pharmaceutical ingredients granulation
- Amino acids, powder fruits, cocoa, coffee and sugar granulation.
- HEC.MC, PVA and CHC isomaltos granulation.
- pigment granulation 
 
Capacity 12 L
Production
Capacity
Min 1.5 Kg , Max 4 Kg
Material Stainless steel 316

4

Apparatus Hot Water Type Vacuum Dryer
Applications Drying of pharmaceuticals, chemicals and foodstuff which are sensitive to the temperature 
 
Temperature 
Range
35 – 150º C
Dimensions 400 * 600*830 mm
Vacuum 
Capacity
10 torr

5

Apparatus Alcohol Recovery Equipment
Applications Alcohol & Acetone Recovery
 
Reboiler 
Capacity
250 L
Production
Capacity
23 – 30 Kg / h
Alcohol 
Purity
90 – 95 %

6

Apparatus Liquid – Solid Separator
Applications - Clarification of dairy products
- Separation and Clarification of two phased liquid 
– solid materials such as milk, drinks , Pigments , etc
 
Clarification 
Capacity
3000 L/h
Discs 
Rotation
Speed
7310 r / min
Material Stainless Steel 316

7

Apparatus Bipyramid Rotating Vacuum Drying Machine
Applications - Drying of chemicals , pharmaceuticals and foodstuff, under vacuum condition
- Drying of heat sensitive materials.
 
Input
Capacity
25 L
Applicable 
Vaccum
Pressure
- 0.9 bar
Material Stainless Steel 316

8

Apparatus Rotary Vacuum Evaporator
Applications Thickening of the liquids and Solvents evaporation under vacuum condition.
 
Feed
Capacity
25 L
Operational
Vacuum
amount
0.06 – 0.07 Mpa

9

Apparatus Filter Press
Applications - wide application in chemicals , pharmacy , metallurgy, ceramics, sugar refining, pigment dyestuffs, cement, silicate, municipal and industrial sludge dewatering and so on . 
 
Input
Capacity
&
Filtration
Level
15(1 m2) , 40 (3m2), 91 ( 6m2) L

10

Apparatus Basket Centrifuge
Applications Materials filtration and separation of the solids from the mother liquid
Capacity 5 , 6 , 20 , 42 L
Loading 
Weight
9 , 10 , 21 , 70 Kg
Material Stainless Steel 316

11

Apparatus Hydrogenation Reactors
Applications Execution of the under pressure hydronization reactions
Input
Capacity
20 , 100 L
Working 
vacuum 
pressure & 
Temperature
30 atm , 300º C
Accessories Temperature & pressure Indicators
Material Stainless Steel 316

12

Apparatus Glass Lined Reactor
Applications - Reflux 
- Distillation 
- Applicable to the most organic solvents , Acids , bases excluding hydrofluoric acids and concentrated phosphoric acid at high temperatures
Applicable 
Capacity
50 L
Operational
Temperature
&
pressure
0-180º C , 0.2 Mpa
Accessories PH & Temperature Indicators
Material Stainless Steel 316

13

Apparatus Glass Lined Reactor
Applications - Reflux 
- Distillation 
- Applicable to the most organic solvents , Acids , bases excluding hydrofluoric acids and concentrated phosphoric acid at high temperatures
Applicable 
Capacity
100 L
Operational
Temperature
&
pressure
0-180º C , 0.2 Mpa
Accessories PH & Temperature Indicators
Material Stainless Steel 316

14

Apparatus Glass Lined Reactor
Applications - Execution of the reactions in pharmaceutical class action 
- Applicable to the most organic solvents , Acids , Bases excluding hydrofluoric acid and concentrated phosphoric acid at high temperatures
Applicable 
Capacity
200 L
Temperature
System
Self Heating without condenser
Accessories PH & Temperature Indicators
Material Stainless Steel 316

15

Apparatus Steel Reactors Equipped with Distillation System
Applications - Execution of the chemical reactions 
- Thickening & distillation of liquids
Applicable 
Capacity
100 , 200, 300 L
Accessories Temperature , Pressure and level Indicators
Material Stainless Steel 316

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