To avoid cross contamination the equipment must be cleaned thoroughly. This is been done by selecting the hard to clean area of the equipment which we call it as hot spots. This is done based on the MHRA regulatory guidelines.

1. HOT SPOT’s IN
EQUIPMENT
Joan Vijetha R
Executive- Producton
Medopharm Pvt. Ltd

2. WHY?
WHAT IS CLEANING
WHAT IS HOT SPOT
OBJECTIVE
NEED
WHAT HAVE WE DONE
EXAMPLES FOR HOT SPOTS IN
CONTENT

3. WHY?
Ineffective cleaning can lead to adulterated
product

4. WHAT IS CLEANING
Cleaning is an essential component of
manufacturing process that prevents
contamination of product from carryover
residue from previous product and also any
foreign matter of physical/
chemical/microbiological in nature

5. WHAT IS HOT SPOT
ION
An area/part/component/section of an
Equipment which is difficult to reach or
difficult to clean because of its design
and which might lead to possible
contamination or cross-contamination if
not cleaned adequately.

6. OBJECTIVE
To protect product integrity

7. NEED
- Removal of product residues
- To avoid degradation of product,
preservatives, excipients or cleaning agents
- Cross-contamination, dust and dirt build-up
- Any adverse effect on the quality of products

8. WHAT HAVE WE DONE
o
Identified Included Implement

9. IDENTIFIED
• The area/part/component/section that were
hard to reach to clean
• The area/part/component/section which is
easily ignored
• Parts where proper cleaning is not done

10. EXAMPLES FOR HOT SPOTS IN
UPPER AND LOWER PUNCH TIPS AND INNER DIA OF THE
DIES
CORNERS OF THE
HOPPER
SHANK HOLE HAND WHEEL

11. EXAMPLES FOR HOT SPOTS IN
CLAMP AND INNER SURAFCE OF THE DUST EXTRACTION
NOZZLES AND PIPE
0
BOTTOM FLOOR OF THE
MACHINE

12. EXAMPLES FOR HOT SPOTS IN
HOLES OF THE SIEVE
FIXING CLAMP INNER SURFACE OF THE HOPPER DISCHARGE
PORT

13. EXAMPLES FOR HOT SPOTS IN
INNER SURFACE OF HOPPER
HOLE OF THE SCREEN JOINTS AND EDGES OF THE
BLADES
EDGES OF THE GASKET

14. EXAMPLES FOR HOT SPOTS IN
CLAMPS AND EDGES OF
GASKET
JOINTS AND CLAMPS OF MIXING
BLADES
DISCHARGE PORT AND
BUTTERFLY VALVE ASSEMBLY
INNER SURFACE CORNERS
OF OCTAGONAL BLENDER

15. EXAMPLES FOR HOT SPOTS IN
INNER SURFACE OF PTS HOSE
PIPE
CORNERS OF INNER SURFACE
OF PTS
CLAMPS AND EDGES OF
GASKET OF PTS
CLAMPS AND CORNERS OF INNER
SURFACE COLLECTION TANK

16. EXAMPLES FOR HOT SPOTS IN
INNER SURFACE OF
THE DISCHARGE PORT
INNER SURFACE OF THE
DISCHARGE PORT
BLADE AND GASKETS PURGING
SYSTEMS
INNER CORNERS
BLADE OF THE RMG

17. EXAMPLES FOR HOT SPOTS IN
INLET AND OUTLET
VALVE OF THE UPPER
AND LOWER PLENUM
EDGES OF THE SEALING AND
LOWER PLENUM GASKET
SUSPENDING RINGS FILTER BAG ASSEMBLY
LOCKS AND ROPE
HOLES OF THE MESH

18. EXAMPLES FOR HOT SPOTS IN
INNER SURFACE OF THE
SILICON TUBES
INNER SURFACE OF THE
AUTOCOATER MACHINE AND
CORNERS AND EDGES OF THE
BAFFLE
NOZZLE OF THE SPRAY
GUN ASSEMBLY

19. EXAMPLES FOR HOT SPOTS IN
JOINTS AND EDGES OF
PNEUMATIC STIRRER
INNER SURFACE OF THE
HOPPER
INNER SURFACE OF THE
RECIRCULATING AND
DISCHARGE PIPE

20. EXAMPLES FOR HOT SPOTS IN
JOINTS AND EDGES OF
PNEUMATIC STIRRER
INNER SURFACE OF THE
HOPPER
INNER SURFACE OF THE
RECIRCULATING AND
DISCHARGE PIPE

21. EXAMPLES FOR HOT SPOTS IN
CORNERS OF THE INNER CHAMBER GRILLS
CORNERS OF THE TRAY DRIERS TRAY

22. INCLUDED
• By including the photographs as an
annexure in Line Clearance SOP’s
• And by including the Hots spots in Line
Clearance format by using “*” symbol for
easy verification during the stage of line
clearances.

23. CLEANING AND LINE CLEARANCE
Date
Product : Batch no.:
Previous product: Batch no.:
Sr. No. Description Std. Time
for verifica-
tion
Day 1 Day 2
Cleaned by/
Done by
Checked by Verified by
IPQA During
line clearance
Cleaned by/
Done by
Checked by Verified
by IPQA
During line
clearance
Type of Cleaning and Type of Line Clearance
(Specify reason in case of repeat line clearance)
Type A /  Type B
Fresh Line-clearance/
Repeat Line Clearance
Type A / Type B
B.COMPRESSION MACHINE (35 ST)
*1. Cleanliness of the Hopper 30sec
2.
Cleanliness of Machine top cover
checked
30sec
*3. Cleanliness of the Shank hole 30sec
*4. Cleanliness of the hand wheel 30sec
*5. Cleanliness of punching tool checked. 2min
6. Cleanliness of the body checked 1min
7. Cleanliness of Lower portion of machine
checked
30sec
*8. #Cleanliness of bottom floor of machine
checked
30sec
*9. Cleanliness of dust extraction nozzles
and pipe checked.
30sec
10. Cleanliness of Supply ducts and return
filters of AHU checked.
2min
11. Ensure that all the barriers surrounding
the compression machine are in good
working condition and closing properly.
1min
Sign/ Date

24. IMPLEMENT
• We have implemented this by proving
mirrors and torch lights to ensure and see if
the hard to reach areas are cleaned
thoroughly or not

25. TRAINING AND MONITORING
• operator
• Production Executive
• IPQA Executive

26. Special thanks to:
Ravin pawar Sir(General Manager)
Ranjith Sir(QA-Head)
Manjunath Sir(QA-Manager)
And to all my Production team

28. REFERENCE
• http://apps.who.int/medicinedocs/en/d/Js5
517e/20.4.13.html#Js5517e.20.4.13
• http://jipbs.com/volumearticles/fulltextpdf/8
_jipbsv1i105.pdf