Article 14 Cleaning

Procedures for cleaning referred to in point (d) of Article 11 shall cover the following, if applicable:

1. (a)

   techniques to be used, including rinsing;

2. (b)

   description of the accessories required for cleaning process;

3. (c)

   identification and concentration of chemicals required for cleaning;

4. (d)

   identification of water quality to be used;

5. (e)

   limits and monitoring of chemical residues remaining on the single-use device;

6. (f)

   limits on process parameters, including temperature, concentration of solution(s) and exposure time to be used.