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P.Ramasubramaniyan et al.
Research Article
Article Received on
16 August 2013,
ABSTRACT
*Correspondence for
Author:
* Dr. P. Ramasubramaniyan,
such as compression force, turret rpm and feeder rpm were studied.
Professor, Department of
Pharmaceutics, Sankaralingam
Bhuvaneswari College of
three different speeds and the best results were obtained at the
optimum speed (40 rpm).
KEYWORDS:
Qualification,
validation,
design,
installation,
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P.Ramasubramaniyan et al.
Execution of protocol and data collection, interpretation and review of data for accuracy,
completeness and cGMP compliance.
Approval of original protocol formats, approval for the final summaries and system
qualification statement.
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P.Ramasubramaniyan et al.
It includes the development and approval of an IQ, OQ, PQ protocols followed by the
performance of IQ, OQ, PQ. The further step includes the workout and approval of IQ, OQ,
PQ reports.
Procedure Followed for Performance Qualification:
The blend/dummy material was unloaded into the hoppers on the both sides and the
compression machine was operated at low speed (20RPM) as per operating instructions. Then
the machine was set to run for 20 minutes continuously after adjusting the following
parameters.
1. Individual tablet weight variation
2. Weight of 20 tablets
3. Hardness
4. Thickness
5. Disintegration time, Friability
Then the experiment was repeated at both medium (40RPM) and high speed (60RPM)
with same set of parameters and the parameters were checked at different speeds (low,
medium and high rpm). The results were reported
.
Sampling Plan
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P.Ramasubramaniyan et al.
(20RPM), medium (40RPM) and high (60RPM) speeds of machine. The results shown here
are the one observed at medium speed (40RPM) which is found to be optimum.
TABLE No. 2
Speed: Medium (40rpm)
Feeder rpm: LHS: 52, RHS: 56
Turret rpm:40RPM
Compression Force (KN): LHS: Main:16.9, Pre:5.7 RHS: Main:17.1, Pre:6.2
S.
PARAMETER
ACCEPTANCE
TIME INTERVAL (RHS)
No.
CRITERIA
0 min 05
10
15
20 min
min
min
min
1
Weight of 20 tablets
21.28 2%
21.28
21.29 21.28
21.24 21.26
(20.85 21.71g)
2
Disintegration Time
NMT 20 min
11'31" 13'03" 10'31" 11'15" 12'52"
3
Friability
NMT 0.8% w/w
0.36
0.44
0.40
0.34
0.41
TABLE No. 3
Time / No. Individual Weight Variation of the tablet : 1.064 5.0% (1.011 1.117 g)
of Tablets Speed: 40rpm
1
2
3
4
5
6
7
8
9
10
0
LHS 1.061 1.060 1.057 1.067 1.070 1.059 1.059 1.062 1.059 1.059
min RHS 1.053 1.064 1.076 1.060 1.058 1.061 1.057 1.064 1.059 1.065
05
LHS 1.054 1.045 1.061 1.067 1.063 1.061 1.060 1.059 1.066 1.055
min RHS 1.063 1.067 1.070 1.059 1.072 1.071 1.075 1.065 1.051 1.055
10
LHS 1.057 1.066 1.053 1.059 1.053 1.071 1.069 1.050 1.070 1.059
min RHS 1.052 1.065 1.067 1.057 1.056 1.064 1.066 1.055 1.067 1.056
15
LHS 1.065 1.066 1.059 1.058 1.063 1.060 1.064 1.047 1.063 1.061
min RHS 1.054 1.064 1.063 1.058 1.055 1.063 1.059 1.057 1.075 1.059
20
LHS 1.042 1.049 1.056 1.056 1.060 1.051 1.064 1.056 1.059 1.056
min RHS 1.054 1.056 1.043 1.043 1.065 1.054 1.056 1.053 1.046 1.058
TABLE No. 4
Time / No.
of Tablets
0
LHS
min RHS
05
LHS
min RHS
10
LHS
min RHS
15
LHS
min RHS
6
6.94
6.98
6.84
6.96
6.88
6.92
7.01
6.94
7
6.93
6.98
6.86
6.94
6.89
6.93
7.0
6.93
8
6.94
7.01
6.89
6.98
6.98
6.94
6.98
6.94
9
6.90
6.96
6.86
6.97
6.93
6.94
6.99
6.93
10
6.92
6.96
6.92
6.87
6.92
7.00
6.94
7.00
20
min
6.99
6.89
6.93
7.0
6.94
6.96
6.98
7.01
6.98
7.0
6.94
6.98
LHS
RHS
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6.89
6.96
6.94
6.98
6.95
6.94
6.98
6.89
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P.Ramasubramaniyan et al.
TABLE No. 5
Time / No. Hardness: 10.0 - 16.0 kp
of Tablets
1
2
3
4
12.8
14.0
14.6
0
LHS 13.6
min RHS 12.6
13.1
13.6
12.8
5
15.2
13.4
6
13.7
13.6
7
13.8
12.8
8
14.2
14.6
9
14.6
14.8
10
14.8
13.8
10
min
LHS
RHS
LHS
RHS
14.0
12.8
13.6
13.8
14.6
12.6
13.8
13.8
14.2
12.4
14.1
14.2
13.6
13.8
14.7
14.7
13.8
13.8
13.5
14.9
13.2
14.2
13.4
13.6
12.6
14.4
14.9
13.4
12.2
13.8
15.0
13.4
14.0
14.2
12.8
12.6
14.2
14.6
13.3
12.7
15
min
20
min
LHS
RHS
LHS
RHS
12.7
14.8
14.9
14.8
12.7
14.1
12.9
12.8
13.6
14.6
12.8
12.6
13.5
13.6
14.6
14.6
14.2
13.6
14.7
14.1
14.5
13.2
14.1
14.2
14.6
14.4
14.4
14.5
14.9
14.5
14.4
14.6
14.8
14.3
13.9
13.9
14.8
14.2
13.6
13.8
05
min
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P.Ramasubramaniyan et al.
ACKNOWLEDGMENT
We express our sincere thanks to our Principal Dr.P.Solairaj and management of
Sankaralingam Bhuvaneswari College of Pharmacy, Sivakasi for providing us the required
facilities. We also like to thank all the members involved in this work for their immense
support and cooperation.
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