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ISSN: 2278-6074
Research Article
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INTRODUCTION
Contamination of pharmaceutical product
instruments/ facility. For example, Code of
with
other
pharmaceutically
active
Federal Regulations (CFR) Title 21, Volume
ingredients and microorganisms are the
4, Section 211.67, states: Equipment and
real concern which questions the integrity
utensils shall be cleaned, maintained, and
and safety of the pharmaceutical product.
sanitized at appropriate intervals to
Drug tragedy of sulfanilamide elixir which
prevent malfunctions or contamination that
killed over 100 people is a classical example
would alter the safety, identity, strength,
of pharmaceutical contamination. In most
quality or purity of the drug product
cases contamination of pharmaceutical
beyond the official or other established
products occurs when a common facility is
requirements" and additionally, Section
utilized to manufacture many products.
211.182 requires that cleaning procedures
Hence regulatory agencies such as the
must be documented appropriately, and
Unites States Food and Drug Administration
that a cleaning and use log should be
(USFDA), European Medicinal Evaluation
established [1,2].
Agency (EMEA), Australia's Therapeutic
The most common and practical solvent is
Goods Administration (TGA) established
water
being
non-toxic,
economical,
requirements for cleaning of such
environment friendly and does not leave
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ISSN: 2278-6074
ISSN: 2278-6074
Equipments
Sampling point
Observation
50L SS vessel
No visual residue
10 KL Manufacturing Tank
Ventury
5
6
7
10 KL holding Tank
10
11
12
13
14
15
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
No visual residue
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ISSN: 2278-6074
Equipments
Sampling point
Residue in
mg/swab
50L SS vessel
Bellow LOQ
Bellow LOQ
Bellow LOQ
Bellow LOQ
Bellow LOQ
10 KL Manufacturing Tank
Ventury
Bellow LOQ
Lobe pump
Bellow LOQ
Bellow LOQ
Bellow LOQ
Bellow LOQ
Bellow LOQ
Bellow LOQ
Bellow LOQ
Bellow LOQ
10 KL holding Tank
10
11
Bellow LOQ
12
Bellow LOQ
13
Bellow LOQ
14
Bellow LOQ
15
Bellow LOQ
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ISSN: 2278-6074
Equipments
Sampling point
TAMC
CFU/swab
50L SS vessel
13
10 KL Manufacturing Tank
22
Ventury
12
13
17
10
22
18
24
19
26
17
22
5
6
7
10 KL holding Tank
10
11
12
13
14
15
REFERENCES
1. Jose A., Morales S. Equipment Cleaning
2.
3.
4.
5.
6.
20
13
14
24
18
23
30