Friabilator Operation Cleaning {Friability Test Apparatus Procedure of Tablets}

Renee

8 years ago

Friabilator – Operation & Cleaning:

Friabilator Operation Cleaning {Friability Test Apparatus Procedure of Tablets}

Friabilator Operation

Start

↓
Connect power cord to an
appropriate electrical outlet

↓
Unscrew locking nut to release drum

↓
Brush any loose dust from tablets

↓
Accurately weigh tablets

↓
Load tablets into drum

↓
Place plastic cover over drum

↓
Hold cover firmly in place and

↓
slide drum onto the shaft

↓
Place locking nut onto the end of the shaft

↓
Tighten locking nut into position

↓
Turn timer to the desired

↓
number of rotations

↓
Wait until drum returns
to stationary position

↓
Remove locking nut

↓
Carefully remove drum from shaft

↓
Remove tablets and brush away
any loose powder

↓

Any cracked, cleaved
or broken tablets

↓
Tablets sample has failed the friability test

↓
Reweigh tablets

↓
Calculate the percentage weight loss using
the following formula:

↓
% Weight Loss = (Initial weight – Final
weight) /

This Standard Operating Procedure (SOP) applies to the staff and students using the Friability Tester in the laboratories of the Pharmacy Department

Standard Operating Procedure SOP FOR OPERATION AND CLEANING

1.0 PURPOSE:
To provide a written procedure for operation and cleaning of the Automated Friabilator EF-2 (USP) .

2.0 SCOPE:
Applicable to determine Friability of tablets in Manufacturing.

3.0 RESPONSIBILITY:
Executive Manufacturing,Executive QA and Assistant Manager QA.

4.0 ACCOUNTABILITY:
Manager Quality Assurance

5.0 DEFINITIONS:
Tablet friability can be used to measure efficiency of tabletting equipment or as an indicator of formulation suitability as well as routine QC functions. It can also be thought of as measuring “dusting”. Tablets are rotated in a plastic drum for a specified period of time. A gravimetric determination is then made to quantitate the amount of surface material that has worn off.

6.0 PROCEDURE:

Friabilator

6.1 OPERATION:

6.1.1

Check cleanliness of the equipment.

6.1.2 Switch ON the instrument, drum will initialize itself to the loading position, the display will now show START.

6.1.3 Weigh and record the weight of the tablets.

A. For the tablets having individual weight up to 0.650 g take 20 tablets.
B. For the tablets having individual weight above 0.650 g take 10 tablets.

6.1.4 Adjust the counts to 100 by pressing the COUNT key followed by ‘1’, ‘0’, ‘0’ keys. (Count range 1 to 99999).

6.1.5 Press ENTER to confirm the reading.

6.1.6 To see and confirm the number of counts press COUNT key.

6.1.7 On confirming the number of counts press RUN/HALT key to start, the display shows the elapsed count.

6.1.8 NOTE: Test can be performed by adjusting ‘TIME’ similarly as ‘COUNT’.

6.1.9 When test is over drum rotates in reverse direction discharging the tablets in the tray.

6.1.10 The test over is indicated by an audible beep and display shows END

6.1.11 The drum initializes itself to loading position and display shows START indicating the instrument is ready for the next run.

6.1.12 Remove the tablets from the tray.

6.1.13 De- dust and weigh the tablets and note down the weight of the tablets.

Calculate the percentage loss in the weight by using the formula

Percentage Loss =Initial Wt – Final Wt/Initial Wt X 100

Notes :
• Do not hold the drums while rotating.
• After testing destroy the tablets.

6.2 CLEANING: Friabilator

6.2.1 Remove the knob on the shaft by pressing the button.

6.2.2 Pull the outside drum out from the shaft carefully. Similarly remove the inside drum by pulling it outside.

6.2.3 Remove the detachable disc from the drum by pulling it outside of both the drums.

6.2.4 Clean both the drums with clean cloth.

6.2.5 Remove both the trays.

6.2.6 Clean the trays with clean cloth.

6.2.7 After cleaning, put the drums and trays back on its position.

7.0 REFERENCES:

References

British Pharmacopoeia 2009 Vol 4. London: The Stationary Office; 2009. P. A438-A439.

Chourasia A, Mishra BJ, Mishra R, Kannojia P. Comparative in vitro Evaluation of Government Hospital Supplied and Commercial Brands of Paracetamol Tablets. The Pharmacist 2007; 2 (2): 37-39.

Huynh-Ba K, editor. Handbook of Stability Testing in Pharmaceutical Development. New York: Springer; 2009. p. 215-216.

Salman AD, Ghadiri M, Hounslow MJ editors. Volume 12 Particle Breakage. The Netherlands: Elsevier; 2007. p. 960-962.

Varian. Friability Tester Operator’s Manual. North Carolina: Varian Inc;
2006.

Handling of friabilator appratus
8.0 6. Precautions

6.1. Do not open the electical compartment due to the risk of shock and allow only trained personnel to do so.

6.2. When tightening the locking nut, ensure that it is not overtightened since this can cause damage to the drum.

6.3. Do not use cleaning compounds containing ammonia or abrasive cleaners to clean the plastic drum since such compounds may damage plastic, causing it to crack and fracture.

6.4. For tablets with a unit mass equal to or less than 650mg, a sample of tablets corresponding as near as possible to 6.5g is to be used whilst for tablets with a unit mass greater than 650mg, a sample of 10 whole tablets is to be used.

6.5. According to the British Pharmacopoeia, 100 rotations are considered to be the standard number of rotations to be used for each test.

6.6. According to the British Pharmacopoeia, a maximum loss of mass not greater than 1.0 per cent is considered acceptable for most types of tablets.
9.0 ABBREVIATION:

9.1 Wt: Weight.
Tablet friability can be used to measure efficiency of tabletting equipment or as an indicator of formulation suitability as well as routine QC functions. It can also be thought of as measuring “dusting”. Tablets are rotated in a plastic drum for a specified period of time. A gravimetric determination is then made to quantitate the amount of surface material that has worn off.