Scribd
Upload
1K views11 pages

Coating Equipment Performance Qualification

The document describes the objectives and process of coating tablets. The objectives of coating include protecting the tablet from stomach acid, protecting the stomach lining, providing delayed release, and maintaining tablet shape. The coating process involves tablets rotating in a drum and being sprayed with coating solution and dried with heated air. Performance qualification of coating equipment involves checking parameters like temperature, spray rate, and coating thickness at intervals to ensure proper operation.

Uploaded by

Osama Mahmoud
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
1K views11 pages

Coating Equipment Performance Qualification

The document describes the objectives and process of coating tablets. The objectives of coating include protecting the tablet from stomach acid, protecting the stomach lining, providing delayed release, and maintaining tablet shape. The coating process involves tablets rotating in a drum and being sprayed with coating solution and dried with heated air. Performance qualification of coating equipment involves checking parameters like temperature, spray rate, and coating thickness at intervals to ensure proper operation.

Uploaded by

Osama Mahmoud
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 11

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 Preparation
Loading
Warming
Spraying
Drying
Cooling
Unloading
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.
Performance Qualification Procedure

S. Ingredients Spec A.R.No/ Qty/ Qty/ Tareweigh Gross Net person Date
No. B.No Tablet Batch t we Weight
(mg) (g) (g) igh (g)
t
(g)

1 8mm SC round
tabltes
2 Insta coat Universal
white
3 Purified Water w/w

Total

pH, Wt/mL
S. No. COATING CHECK Set parameters Initial 15 mts 30 mts 45 mts 60 mts
PARAMETERS
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 Set Initial 15 mts 30 mts 45 mts 60 mts
PARAMETERS paramet
ers
11 Spray off time, sec 15 sec
12 Average core weight, mg 195.00mg

13 Average Weight of coated 200.00mg


tablet, mg

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 2%


gain
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.

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy