Coating Equipment Performance Qualification

Objectives of Coating:

Protects the tablet (or the capsule contents) from stomach acids

Protects the stomach lining from aggressive drugs such as enteric coated aspirin

Provides a delayed release of the medication

Helps maintain the shape of the tablet

Coating Process Design & Control

Tablet coating takes place in a controlled atmosphere inside a perforated rotating drum.

Angled baffles fitted into the drum and air flow inside the drum provide means of mixing the tablet bed.

As a result, the tablets are lifted and turned from the sides into the centre of the drum, exposing each tablet surface to an even amount of deposited/sprayed coating.

The liquid spray coating is then dried onto the tablets by heated air drawn through the tablet bed from an inlet fan.

The air flow is regulated for temperature and volume to provide controlled drying and at the same time, maintaining the drum pressure slightly negative relative to the room in order to provide a completely isolated process atmosphere for the operator.

Tablet coating equipment may include spray guns, coating pan, polishing pans, solution tanks, blenders and mixers, homogenizers, peristaltic pumps, fans, steam jackets, exhaust and heating pipes, and filters.

The coating process is usually a batch Process.Coating Solution PreparationLoadingWarmingSpraying DryingCoolingUnloading

Pre-requisites for Performance Qualification

Equipment should perform as defined in the PQ protocol with all Utilities connections.

The training has been imparted to the execution team for conducting performance qualification.

The master calibrator are available (its calibration should be traceable to NIST) for calibration of instruments.

S.No.

Ingredients Spec A.R.No/B.No

Qty/Tablet(mg)

Qty/Batch(g)

Tareweight

(g)

Gross weight

(g)

Net Weight(g)

person Date

1 8mm SC round tabltes

2 Insta coat Universal white

3 Purified Water w/w

Total

pH, Wt/mL

Performance Qualification Procedure

S. No. COATING CHECK PARAMETERS

Set parameters Initial 15 mts 30 mts 45 mts 60 mts

1 ACTUAL TIME PERFORMED

2 Pan Size 300mm

3 Pan RPM 10

4 Inlet Temp °C 75°C

5 Tablet bed Temp °C NA

6 Exhaust Temp °C NA

7 Atomization pressure, kg/cm2 4.0-4.5kg/cm²

8 Peristaltic pump RPM 2

9 Spray rate, g/ml 12 g/ml

10 Spray on time, sec 55 sec

S. No. COATING CHECK PARAMETERS

Set paramet

ers

Initial 15 mts 30 mts 45 mts 60 mts

11 Spray off time, sec 15 sec

12 Average core weight, mg 195.00mg

13 Average Weight of coated tablet, mg

200.00mg

14 Disintegration Time, mts

15 Thickness, mm 3.72mm

16 Colour shade variation (PO) No Variation

17 Picking & sticking (PO) Nil

18 Blistering/cracking (PO) Nil

19 Weight gain and % weight gain

2%

Acceptance criteria: Process should be smooth without any of the following problems.

1. Set temperature should be maintained.

2. Spray gun and tubes should not be choked and coating should be uniform.

3. Amount of solids spray and weight build up should be well within not less than 75%

4. Coated tablets should smooth with out any coating defects.