Page 36 - Clean India Journal Magazine June 2019 Issue

MARKET REPORT

strength to higher strength. This is also done when the extracted into a known volume of solvent in which
strength remains the same, but the colour/flavour change. the contaminant active ingredient residue is soluble.

It consists partly of clean-in-place, and partly clean-
out-of-place methods. Parameters
Type B (major): This type of cleaning is done between By measuring the levels of certain impurities left on
the manufacture of different kinds of products on the equipment after cleaning, using either of the above
the same equipment or when there is changeover of methods, one can determine the efficacy of cleaning:
manufacture of the drug from higher strength to lower • Total Solids: Quantities of non-volatile liquid in
strength. It is also carried out at the end of each working liquid extracts, either in rinses or swabs results of
day. the surface. Used for both organic and in-organic
This comprises only clean-in-place methods. materials.
Type C: For the processing rooms which are not used • pH test: for determining the presence of alkaline or
during the day. acid cleaning materials in the final rinse.
• Specific Ion Meters: for quantifying low levels of
Cleaning Validation specific ions generally from ionic materials. Useful
for confirming the level of residual acidic or basic
Cleaning procedure must effectively remove detergents in the final rinse, as determined by the pH
residues of a product and a cleaning agent from the test.
manufacturing equipment, to a level that does not raise
patient safety concerns. Validation of cleaning methods
provides documented evidence that an approved cleaning US-FDA Standards
procedure will provide clean equipment, suitable for its The US Drug authority has mandated certain standards
intended use. for acceptable levels of impurities – either from cleaning
Cleaning validation is done by one of two common chemicals or previously manufactured drugs – in a fully
methods: processed unit sold to consumers:
• Rinse samples: Analytical determination of a sample • Not more than 0.1% of the normal therapeutic dose
of the last rinsing solvent used in the cleaning (amount used in a single dose for treatment) of any
procedure. The volume of solvent used for the last product should appear in the maximum daily dose
rinse must be known. of the product that is manufactured on the same
• Swab sampling: Based on the physical removal of equipment, after it.
residue left over on a piece of equipment after it has • Not more than 10ppm of any product to appear in
been cleaned and dried. A swab wetted with a solvent another product.
is rubbed over a previously determined sample • No quantity of residue to be visible on the equipment
surface area to remove any potential residue, and after cleaning procedures are performed. CIJ

36 Clean India Journal www.cleanindiajournal.com
June 2019