Cleaning Validation Studies

to CFR Title 21 Part 211.67

The Code of Federal Regulations Title 21 CFR 211.67 s t

ates“ Equipme nta ndu tensil
ss hall beclea
ned,
maintained, and sanitised at appropriate intervals to prevent malfunctions or contamination that would alter the
safety, identity, strength, quality, or purity of the drug product beyond official or other published
require me nts.”

 TOC is a quick, accurate and inexpensive screening protocol for contamination validation of small
molecule drugs, peptides, proteins, and cleaning detergents.

 It can be utilised in conjunction with both CIP (cleaning in place) and COP (cleaning out of place).

 Application areas for aqueous based samples typically include:- ultrapure water (water for injection-
(WFI)) sample analysis (<20ppb), pharmaceutical applications (<500ppb), and drinking water (<5ppm).

 TOC can be operated under full GLP protocols if required.

 TOC can be used with all relevant standard sampling methods such as swabs, wipes, rinse, and
immersion techniques though the most consistent results are obtained by using a single method.

 The amount of carbon containing contamination is seen as the worst case scenario i.e. where all the
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contaminant(s) can be identified and quantified using M-Scan’sexte nsi
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chromatography/mass spectrometry equipment.

 Measurement options include:

Total Carbon (TC) with a measurement range of 0 ~ 3000 mg/L,
Inorganic Carbon (IC) with a measurement range of 0 ~ 2500 mg/L,
Total Organic Carbon (TOC) and Non-Purgable Organic Carbon (NPOC)
All methods have short analysis times and typically require sample volumes in the 350 ~ 20,400 µl
range.

For further information please feel free to contact:

M-Scan Ltd M-Scan Inc M-Scan SA
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Call: Mark Millichip Dr Mark Rogers Dr Luc-Alain Savoy

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