Cleaning Validation Document No:

Protocol
Powder Dosing Machine Effective Date:
Revision No: Page No: Page 1 of 4

1. PREAPPROVAL OF PROTOCOL:

Compiled By:
Functional area Name Signature Date
Quality Control

Production
Quality
Assurance

Reviewed and Approved By:

Functional area Name Signature Date

Quality Control

Production
Quality
Assurance

Authorized By:
Functional area Name Signature Date
Head-
Quality
Assurance
 Cleaning Validation Document No:
Protocol
Powder Dosing Machine Effective Date:
Revision No: Page No: Page 2 of 4

2.OBJECTIVE:
The objective of this protocol is to demonstrate that the cleaning procedure SOPXX
for powder dosing machine, will successfully and consistently reduce the level of
residues
to a predetermined level of acceptability, so as to prevent contamination (product
or cleaning
process related from adversely affecting the safety and quality of the next product
manufactured.

3.SCOPE:
This protocol will cover the cleaning process of the powder dosing machine for the
CPS
products. As per the CVMP grouping matrix, products are divided into various
groups
based on their
a. Water solubility
b. Therapeutic dosage
c. Toxicity
d. Batch size (in kg)
From each group, one worst-case product is considered for cleaning validation.
However, only three products are manufactured in this category; therefore, one of
three
products are selected for cleaning validation.

4.RESPONSIBILITY

5.DESCRIPTION OF THE CLEANING PROCESS

The powder dosing machine should be cleaned manually as per
SOP#CPS_PR603_00
1. Pour 10 L PW on the accessories. For silicone tubes, connect the end of the
hose of PW to
2. silicone tube and flow PW inside the tube at least 5 minutes.
 Cleaning Validation Document No:
Protocol
Powder Dosing Machine Effective Date:
Revision No: Page No: Page 3 of 4

3. Use a cleanroom sponge soaked in Teepol solution to rub and remove stains
of powder off.
4. Rub all surfaces of accessories and outside of silicone tubes.
5. Rinse all accessories by 10 L PW.
6. Final rinse all accessories by 10 L WFI.
7. Place them into a tray and close the lid immediately.
8. sterilization as per SOP operation of sterilizer.

6.SELECTION OF WORST-CASE WORST-CASE PRODUCT:

6.1Evaluation of the product to select the worst-case
product
Product Solubility(water) Toxicity Decision
Ceftriaxone Sodium 0.47 g/ml
Equivalent to
Ceftriaxone base 1
gram

Cefotaxime Sodium 0.05 g/ml MARKER

equivalent to
Cefotaxime base 1
gram

Pethidine
Hydrochloride
Injection BP

The XX is selected as worst case as their solubility are lowest so possibility residue
will be more.

6.2 Cleaning Limit Selection criteria based on MAC

Approach:
LC SBS
Maximum Allowable Carryover (MAC) = SF LVSD

LC = lowest concentration (in mg)

SBS = smallest batch size made in the same equipment
LVSC = largest volume single concentration (active) of any product made /in the
same
 Cleaning Validation Document No:
Protocol
Powder Dosing Machine Effective Date:
Revision No: Page No: Page 4 of 4

equipment
SF = safety factor = 1000.
Worst case product is
7.Validation Plan
7.1Worst-case condition
The Cleaning SOP