cleaning validation and washing according to ICH guidlines

1. Presented By : Apurva R.
Shukla
CLEANING OF
EQUIPMENT

2. INTRODUCTION
 cleaning validation, the first thing that comes
to mind is “prevention of cross-
contamination”,
 Cleaning of pharmaceutical equipment is
essential to reduce the risk of product
contamination and this can be achieved only
if the cleaning procedure has been validated.
 ICH guidance ICH Q9 (1) encourages that a
quality risk management approach be
considered and that, based on the level of
risk, cleaning processes may be subject to
different levels of validation or verification.

3. Nature of equipment is imp. for selecting
the cleaning method and cleaning agent.
 Material of construction & its compatibility with
cleaning agent.
 Complexity of equipment
 Various angle for cleaning pharma.
Equipment
- Which comes in contact with processing
material
- Which do not come in contact
- Mechanical side of equipment eg. Motor,
gear box, chain etc
- Electrical panels

4. CLEANING METHOD :
 Designing of cleaning method is an imp task.
 Designing starts with addressing minimum
aspect
 What is being clean ? eg. Equipment, facility,
etc
 What are the contaminants ? eg. API, exipients,
MO, endotoxins, oils, particulate matter, dust
and fiber, any other.
 What is the level of cleanliness is
expected ?
 How parameters will be tested ?

5.  Which cleaning equipment to be used ?
Manual, semi automatic, automatic ?
 Who is going to do cleaning ?
 Which cleaning agent will be used and at
what conc. ?
 What is the frequency ?
 Who will write the SOP ?
 What record will be maintain ?

6. CLEANING MECHANISM :
Mechanism totally depends on selection of
cleaning agents and type of residue to be
cleaned
Method involved in cleaning of residue are :
 Dissolution
 Saponification
 Wetting agents
 Emulsifying agents
DISSOLUTION :
 Mechanism involved is solubility of residue in
cleaning agents.
 eg:- SLS , chelating agents etc

7. SAPONIFICATION :
 Mechanism involved is breakage of ester
bond in fat residue to form fatty acid and
glycerol which is soluble in water.
 eg :- NAOH, KOH etc

8. WETTING AGENT :
 Mechanism involved is lower the surface tension
of cleaning solution so that it can easily
penetrate in to residue
 eg ;- surfactants

9. SAMPLING METHODS :
 Equipment should normally be cleaned as
soon as possible after use
 This may be especially important for
operation with topical products, suspensions
where the drying residue will directly effect
the efficiency of a cleaning procedure.
 Two methods of sampling :
1.Swab Method 2.Rinse
Sampling Method

10. SWAB METHOD :
 This method of sampling is the most
commonly used and involved taking an inert
material (eg:-cotton wool) on the end of the
probe(referred as swab) and rubbing it
methodically across the surface.
 The swab are added with dilution solvent and
these solvent were analyzed by suitable
analytical instruments for the presence of
residue of previous products.

11. RINSE SAMPLING METHOD :
 Measured area of a cleaned surface is rinsed
or solvent washed.
 Solvent is collect and test for traces of
contaminants

12. ACCEPTEANCE CRITERIA :
Chemical determination :
a) NMT 0.1% of the normal therapeutic dose of
any product will appear in the maximum daily
dose of the subsequent product,
b) NMT 10 ppm of any product will appear in
another/next product.
c) For certain allergic ingredient, penicillin
cephalosporin of steroid and cytotoxic, the
limit should be below the limit of detection.

13. ACCEPTEANCE CRITERIA :
 Microbial contamination :
 Total aerobic counts
a) Bacterial count :- NMT 20 CFU
b) Molds :- NMT 02 CFU
 Physical determination:
No quantity of residue should be visible on
the equipment after cleaning procedures are
performed

14. DOCUMENTATION :
 The cleaning process should be documented
in an SOP.
 Documentation should be in such a way that
the following Information is readily available:
 The area or piece of equipment cleaned
 The person who carried out the cleaning
 When the cleaning was carried out
 The SOP defining the cleaning process
 The product, which was previously processed
on the equipment being clean.

17. THANK
YOU