The
objective of this protocol is to demonstrate the capability of Sampling Device
for its intended application to deliver sampling and acceptable cleaning level.
CLEANING
PROCEDURE FOR SAMPLING DEVICE FOR QUALIFICATION:
Prior to qualification, sampling
device shall be cleaned as per procedure defined below
a)
Dismantle
hollow pipes and end cap of the sampling device.
b)
Inspect
all parts of sampling device for corrosion, if any.
c) Flush all parts of sampling
device with purified water till removal of any extraneous matter.
d)
Prepare
10% v/v Nitric Acid Solution (HNO3) and kept the sampling device in
Nitric Acid Solution for 8 hours
e)
Drain
the acid solution and clean the device, inner and outside with sufficient qty
of water.
f)
Collect
the rinse samples of water and check the pH of water with pH meter (pH Limit -
Between 6.0 and 7.0).
g)
If
pH found within the limit, follow step no (i) and onwards.
h)
If
pH not within the limit, follow steps (e) and (f) till the pH is found within
the limit.
i)
Inspect
all parts of sampler, visually for removal of extraneous matter,
j)
Dry
all parts of sampling device at room temperature or using hot air drier.
k)
Assemble
the sampling device.
Qualification:
Check
the size and dimensions with calibrated measuring device e.g. measuring tap,
scale etc and record. Check
the smoothness of the surfaces. Check
the MOC of sampling device against the certificate provided by vendor
Performance qualification:
Check the
volume capacity by pouring the water in hollow sampling device and collect in
empty beaker and weight.
Calculation
formula for weight (A): weight of water x density of water
The
observed weight shell be within the ± 15 % of theoretical capacity. Theoretical
capacity shall be taken from vendor in cc or ml.
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