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|Family Name/Surname: Nagubandi |Student ID:6911668 |

|Given Names Aravindsai | |

| |Unit Code and Title:HES 6423 (Finished dosage forms) |

|Phone number/s:0425246889 |Email:aravindsai41@ |

|Due date:24/9/2010 |Word count:1280 |

|Tutor’s name: Helen |Tutorial dates: |

|Title of assignment: GSK technologu evaluation |

I have read the feedback on my previous assignments in this unit/program and tried to take it into account in writing this assignment.

|Yes |y | Not applicable, this is my first assignment in this | |

| | |discipline | |

|No | |Reason? |

| | |………………………Aravindsai……………………………………………………………………….…………………………………………………………………….... |

| | | |

This assignment must be your own work. Plagiarism is the appropriation of the ideas, writings or other work of someone else and passing them off as one’s own.

I have not plagiarised this assignment in whole or in part.

Signed:………………………Aravindsai……………………………………………………………………….….. Date:……24/9/2010………………………

Staff in the Faculty may wish to use your assignment for benchmarking. Also, if it turns out really well, we might want to use it as an example for other students. Do you give permission for your assignment to be copied for these purposes?

|Yes |y | |No | |

Assignments used for benchmarking will be anonymous. But if your work is selected as an example of excellent work for other students to read, may we use it under your name?

|You may use it with my name. |y |

|Please remove my name from the copy you use. | |

Signed:…………………Aravindsai…………………………………………………………………………….….. Date:………………24/9/2010……………

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EXAMINERS INITIALS: DATE:

Table of Contents

About Fette 1200: 3

List of quality control test for tablets: 3

SIPOC diagram: 4

Technological assessment: 5

References: 6

About Fette 1200:

Product manufactured: Combivir

Use: Anti HIV

Equipment batch size: 230,400 tablets per hour

Change over and cleaning: Equipment facilitates easy change over and cleaning due to exchangeable turrets. Cleaning is done for every batch. (If the next batch is of same product then amount of cleaning is low)

This equipment is used for compressing tablets; Solid particles are filled into the die cavity, where a compression force is applied on to the solid particles using the punches results in formation of a tablet. Shape of the tablet depends on the shape of the die and thickness of the tablet is proportional to the distance between the punch tips. (Shayne C. Gad)

According to Rankell, A. S. and Higuchi, T. when force (energy) is applied on the solid particles partial fusion or partial dissolution is developed at the surfaces of particles which aids in the adhesion leading to formation of tablet.

In Fette 1200 the tablet is formed pressing action of punches (upper punch, lower punch) and a die.

• Lower punch located in the die is lowered creating a cavity;

• Depth of lower punch can be controlled (which defines the thickness of tablet) ;

• The upper punch is brought down applying force , leading to a compaction;

• Lower punch is raised and the tablet is ejected;

Advantages:

• High (230,400 tablets per hour) and reproducible performance;

• Easy to validate

• Design facilitates scale-up

• Exchangeable turrets can aid in shortened cleaning time and easy access;

• Can even produce small quantities of tablets without any loss of product;

Disadvantages

• Equipment is expensive;

• Cannot be used for tablets of more than 11mm diameter;

• Cannot be used for materials which need a compression force more than 80 KN;

• Cannot be used for sticky materials;

• Cannot be used for heat sensitive materials;

• Cannot compress material which are sensitive to moisture;

• Cannot compress amorphous materials;

• Cannot compress poor wetting materials (can be directly compressed, but homogeneity cannot be assured due to dry nature) (Leon lachmann)

List of quality control test for tablets:

British Pharmacopeia: Disintegration, Uniformity of weight, uniformity of dispersion, content of active ingredients.

United States pharmacopeia: Bulk density of powder, powder fineness, loss on drying, disintegration test, tablet friability, drug release testing, container permeation test.

SIPOC diagram:

| 1 |

| P |

|Granules enter into equipment through hopper |

|Lower punch located in the die is lowered |

|creating a cavity; |

|Depth of lower punch can be controlled (which |

|defines the thickness of tablet) ; |

|The upper punch is brought down applying force ,|

|leading to a compaction; |

|Lower punch is raised and the tablet is ejected;|

|Ejected tablets are sent for packaging |

|2 |3 |

|O |C |

|Compressed tablet |Packaging line; |

|5 |4 |

|S |I |

|Granulator |Mixed Granules |

| | |

(1) Process - P

(2) Outputs -O

(3) Customers - C

(4) Inputs - I

(5) Suppliers – I

Prior to this process (compression), granulation should be performed hence the supplier here will be granulation process where granulator performs the main task.

Output after the process of compression is a compressed tablet

The process of compression is granulated powder is compressed between upper and lower punch and compressed tablet is ejected

After compression the tablet is sent for packaging and hence the customers for this process are packaging line

Technological assessment:

|Features |Fette 1200 |Korsch technical rotary press 700/900 |

|Tablet output |230,400 tablets per hour | 320.000 Tab/h.  |

|Maximum tablet diameter |11mm |64mm |

|Max. compression force |80KN |100 KN |

|Max. filling depth |18 mm |40 mm |

|Die diameter |22mm |80mm |

|Die height |22.22mm |37 mm |

|Multi-layer tablets |NO |Yes |

|In-process quality control |Yes (with peripheral device, CHECK MASTER 4.1) |No |

|Peripherals |GRATEX( De-dusting, de-burring) |Tablet de-duster, metal detection unit, tablet |

| |CHECK MASTER (in process quality control) |collection system, and tablet sampling unit. |

|Ease of cleaning |Easy because of exchangeable turrets |Designed with quick-disconnect for efficient |

| | |cleaning and changeover. |

|Effectiveness for scale up |Yes (Simplified scale-up through uniform |No |

| |geometry | |

| |of the FETTE presses) | |

|Automated monitoring of equipment’s |No |Features a comprehensive fault diagnostic System|

|performance | |to insure maximum reliability. |

Assessment Criteria:

Assessment depends on the

• Number of tablets required per hour

• Diameter of the tablet

• Layers on the tablet (multilayered etc.)

• Self-diagnostic features

• And effectiveness in scale up procedures.

Advantages and disadvantages:

Both fette 1200 and Korsch technical rotary press 700/900 are good compressing equipment’s, however there are significant differences in their design and operation.

• Tablet output is higher in korsch than fette, here korsch technical rotary press 700/900 is advantageous than fette 1200.

• Maximum tablet diameter in fette is 11mm, where as in korsch technical rotary press 700/900 is 64mm; fette cannot be used for tablets whose diameter is more than 11mm whereas korsch has a broad range.

• Maximum compression force in korsch technical rotary press 700/900 is higher than fette 1200, for the material which need higher compression force korsch technical rotary press 700/900 can be advantageous

• Korsch technical rotary press 700/900 can produce tablets much larger than fette 1200 due to its large fill depth, as controls are also available korsch compression equipment can produce wide range sizes of tablets than fette.

• Korsch technical rotary press 700/900 is design can facilitate multi layered tablet production, but fette design features doesn’t include production of multi layered tablets. Korsch is advantageous for producing multi layered tablets.

• Korsch technical rotary press 700/900 has more peripherals than Fette 1200 compression equipment’s, which includes metal detection, de-dusting etc. But fette as In-process quality checking peripheral (CHECKMASTER) as peripheral which is more advantageous than the korsch.

• Both Korsch technical rotary press 700/900 and fette 1200 are easy to clean by their design of easy removal of parts.

• Fette 1200 has advantage over korsch technical rotary press 700/900 in its design which facilitates scale-up.

• Korsch technical rotary press 700/900 has a special advantage which self-monitors its performance, whereas fette 1200 doesn’t have this facility.

As a conclusion, Korsch technical rotary press 700/900 has more advantages, of producing more tablets, broad range of tablet sizes, layered tablets and it can even monitor its own performance.

References:

Shayne C. Gad ,Pharmaceutical manufacturing handbook: production and processes, Volume 10, Page 1134

Rankell, A. S. and Higuchi, T. (1968), Physics of tablet compression XV. Thermodynamic and kinetic aspects of adhesion under pressure. Journal of Pharmaceutical Sciences, 57: 574–577. doi: 10.1002/jps.2600570405

Leon lachmann, Herberta lieberman, Joseph l.kanig, The Theory and practice of industrial pharmacy , 3rd edition, P- 294

Isadore Kanfer; Shargel, Leon; Kanfer, Izadore (2005). Generic drug product development: solid oral dosage forms. New York, N.Y: Marcel Dekker. ISBN 0-8247-5460-3.

Korsch technical rotary press 700/900 , Brochure, , viewed on 22/9/2010.

Fette 1200, brochure, , viewed on 22/9/2010.

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