Residual limit of cleaning Agent

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Dear member,

  1. Can any one inform me the residual limit of cleaning agent with reference documents.
    In general consideration the residual limit of cleaning agent is 10-100ppm but there is no reference document available.

  2. If the cleaning agent is prepared inhouse e.g. NaOH 3%v/v, what should be the acceptance criteria to determine the residual level.

Regards

2

Limit for Active material residue : 10 ppm

Limit of cleaning agent used (E.g : Teepol / NaOH) : 5 ppm

3

[quote=sojitra_pankaj2003]Limit for Active material residue : 10 ppm

Limit of cleaning agent used (E.g : Teepol / NaOH) : 5 ppm[/quote]

Thanks Can you also provide the reference documents?

4

Cleaning Validation Guidelines (GUIDE-0028)

Carry-over of product residues should meet defined criteria for example the most stringent of the following criteria:

NMT 0.1% of the normal therapeutic dose of any product to appear in the maximum daily dose of the following product;

NMT 10 ppm of any product to appear in another product;
No quantity of residue to be visible on the equipment after cleaning procedures are performed. Spiking studies should determine the concentration at which most active ingredients are visible.

For certain highly sensitizing or highly potent ingredients (such as penicillins, cephalosporins or potent steroids and cytotoxics), the limits should be below the limit of detection by best available analytical methods. In practice this may mean that dedicated plants are used for these products.

5

hi all of you,
I am facing one problem during cleaning validation i have make the matrix and validate the procedure on the basis of product having least soluble and high potent in a area having equipment E1,E2,E3,E4,E5,E6,E7.but a new product consider in that area which is least soluble and high potent in that of previous product so we want to revalidate the procedure but problem is that only E1,E3,E4,E6 equipments are used for manufacturing the new product . then during cleaning validation we consider all the equipments present in area or only those equipments which are use for new product.

thanking
Anil singh
validation analyst