1.0 Purpose
1.1 To describe the General Cleaning procedure after change over and at the end of day operation in order to comply with cGMP standard.
2.0
Scope
2.1 This Sop is applicable for room
cleaning after change over and at the end of the day operation at the Production area of "NAME" Pharmaceuticals
Ltd.
3.0
Responsibility
3.1
Only concern Operator and cleaner
is responsible for normal cleaning. He/ She inform the supervisor about any deviation
from normal operation. He also maintains log book.
3.2
Sr. Officer-
Production/Officer- Production is responsible for monitoring day to day
activity.
3.3
Production Manager/ Head are
responsible for proper execution of the SOP.
4.0 Abbreviations and Definitions
4.1 Type A Cleaning: This type of cleaning is defined as cleaning procedure followed during product to product change over.
4.2 Type B Cleaning: This type of cleaning is defined as cleaning procedure followed during batch to batch of same product.
5.0 Materials and Equipment
5.1 Portable Vacuum Cleaner
5.2 Lint Free Cloth
5.3 Dry Mop
5.4 Round mop with bucket
5.5 Wiper
5.6 Potable / Tap Water
5.7 Purified Water
5.8 Detergent Solution / 0.4% (w/v) Sodium lauryl Sulphate: 4 gm Sodium lauryl Sulphate is dissolved in 1.0 liter of portable / tap water to prepare detergent solution.
5.9 Disinfectant Solution : Solution used to make free from microorganism.
Savlon Solution (5% v/v) :50 ml is mixed with 1.0 liter of tap / portable water to prepare disinfectant solution. Or
Dettol Solution (2.5% v/v) : 25 ml is mixed with 1.0 liter of tap / portable water to prepare disinfectant solution.
5.10 Dehydrating agent : 70 % Isopropyl alcohol (30 ml water in 70 ml Isopropyl alcohol of 100 % concentration)
6.0 Precaution / Health and Safety Considerations
6.1 In Production Department, cleaning should be performed within 48 hours after completion of operation.
6.2 Use disinfectant solution within 24 hours of preparation.
6.3 Use non-shedding materials for cleaning purpose to clean floor, walls, ceiling, sink and waste bin.
6.4 Ensure that products are removed from the room during cleaning.
6.5 Ensure the flexible hoses/pipes are hanged downward after cleaning to avoid deposition of water inside the hoses/pipes.
6.6 Ensure complete removal of documents of previous product.
7.0 Procedure
7.1 Cleaning:
There are two types of cleaning carried out for room after change over.
7.1.1 Type A Cleaning: This type of cleaning is defined as cleaning procedure followed during product to product change over. If the unit or equipment is used for same product, it has to be cleaned after 96 hours.
7.1.1.1 Fix “TO BE CLEANED” labels at all used equipment inside the room and Room.
7.1.1.2 Clean floor, walls, ceiling, equipment, stairs, SS table top, corner of windows, doors, handle of doors and waste bin as described below.
7.1.1.3 Floors, stairs, walls, windows, doors, SS table top and exposed surface of return grill and supply duct.
7.1.1.3.1 Remove the dust from floor with the help of vacuum cleaner, broom or dry clean lint free cloth as required.
7.1.1.3.2 Rinse with potable water to remove dust completely.
7.1.1.3.3 Mop with Savlon Solution (5% v/v) or Dettol Solution (2.5% v/v) as per cleaning schedule.
7.1.1.3.4 Clean all the equipment and their accessories as per respective SOP.
7.1.1.3.5 Let it be dry with the help of Air.
7.1.1.4 Ceiling
7.1.1.4.1 Spray potable water with the help of hose pipe to remove dust completely.
7.1.1.4.2 Let it be dry normally with the help of Air.
7.1.1.5 Waste bin
7.1.1.5.1 Remove waste and transfer to dedicated area for proper waste management.
7.1.1.5.2 Rinse the waste bin with potable water to remove dust completely.
7.1.1.5.3 Let it be dry with the help Air.
7.1.1.5.4 Electric board, switch control panel should be cleaned with dry lint free cloth.
7.1.1.5.5 After completion of cleaning remove “TO BE CLEANED” label and fix “CLEANED” label on the cleaned equipment and room and record the cleaning action in equipment and room cleaning logbook.
7.1.2 Type B Cleaning: For batch to batch of same product.
7.1.2.1 Fix “TO BE CLEANED” labels at all used equipment inside the room and Room.
7.1.2.2 Clean floor, walls, equipment, stairs, SS table top, corner of windows, doors, handle of doors and waste bin with the help of vacuum cleaner or broom or dry clean lint free cloth to ensure the absence of dust.
7.1.2.3 Finally clean with disinfectant soaked cloth.
7.1.2.4 Electric board, switch control panel should be cleaned with dry lint free cloth.
7.1.2.5 Ensure complete removal of documents of previous product.
7.1.2.6 Clean all equipment & their accessories as per respective SOP.
7.1.2.7 After completion of cleaning remove “TO BE CLEANED” label from all equipment and Room and fix “CLEANED” label.
7.1.3 Cleaning at the end of day’s operation.
7.1.3.1 Clean external parts of machine and operating panel with dry clean lint free cloth.
7.1.3.2 Mop the floor with potable water.
7.1.3.3 Finally mop with Savlon Solution (5% v/v) or Dettol Solution (2.5% v/v) on rotated weekly.
8.0
Reference
Document
8.1 In-house
9.0 Annexure
9.1 Annexure-I : Checklist for Type A Cleaning
9.2 Annexure-II : Checklist for Type B Cleaning
9.3 Annexure-III : Format of Manufacturing Area Cleaning Logbook
10.0
Revision
History
|
Revision No. |
Brief reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
11.0 Training
11.1 Head of Production or his nominee give the training of cleaner, production operator and worker.
