Page 28 - Cleaning and sanitation in GMP

GMP Training – Cleaning and Sanitation in GMP Areas by www.gmpsop.com

then, any of this product left on equipment could cause major contamination
risks.

EQUIPMENT HOLD TIME

Once we have completed batch processing, there
must be a maximum hold time between post-use
and the commencement of cleaning. This is because
over time, any residues will start to "bake" onto

POST-USE / equipment surfaces and will be much harder to

PRE-CLEAN clean off. In addition, bio burden may start to grow.

It is required that procedures nominate and validate
maximum allowable hold time. During cleaning, it

is required to commence cleaning before the
maximum hold time has elapsed.

During the cleaning cycle, procedures should
specify a minimum hold time for contact of the

cleaning agents and sanitizers with equipment
DURING THE surfaces.
CLEANING CYCLE
(CONTACT TIME) This is because in order for cleaning and sanitizing
agents to be effective, they must be in contact with
the dirt and surface for a period of time. This
contact time is validated.

Equipment must be stored dry and protected. GMP
rules require that stored equipment must have an
STORAGE "expiry date" or maximum storage time before it
BETWEEN USE needs to undergo re-cleaning.

Most companies have a simple rule: all equipment
is inspected thoroughly before use, and any

Copyright©www.gmpsop.com. All rights reserved
Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited.
Page 28 of 42