Cleaning of Dispensing and Sampling Area

Cleaning of Dispensing and Sampling Area

1.0 Objective
To lay down a procedure for cleaning of dispensing and sampling area.
2.0 Scope
This Standard Operating Procedure is applicable for cleaning of dispensing and sampling area to be

followed at formulation plants of abc Pvt. Ltd. Roorkee.
3.0 Responsibility
3.1 Officer/Executive warehouse shall be responsible for ensuring the cleaning in dispensing and sampling area.
3.2 Head Warehouse is responsible for implementation of this SOP.
3.3 Head QA or his designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
RLAF : Reverse Laminar Air Flow
No : Number
QA : Quality Assurance
WH : Warehouse

5.0 Procedure
5.1 Cleaning: After Product Change Over
5.1.1 Remove the powder dust from walls, ceiling and electrical fixtures using Vacuum cleaner.
5.1.2 Collect the spillage of solid materials from floor and balance using Vacuum cleaner.
5.1.3 Remove dust from inner surface panels and external surface of RLAF shall be cleaned with Vacuum Cleaner.
5.1.4 Clean the Dispensing Area, bench, weigh balance and RLAF body with the wet cloth followed by dry cloth.
5.1.5 Sanitize with the inner surface of the RLAF with 70% Iso Propyl Alcohol solution.
5.1.6 Clean the Fenders with moist lint free duster and clean all the corners of the area with Vacuum Cleaner.
5.1.7 Sanitize the floor using day’s disinfectants solution.
5.1.8 Make necessary entries in the “Cleaning Record” after the activity.
5.2 Cleaning: After Batch To Batch Change Over
5.2.1 Use Vacuum cleaner to remove powder dust from the balance platform and the floor of the Surrounding Area.
5.2.2 Clean the inner panels and external surface of RLAF vacuum cleaner and dry with cloth.
5.2.3 Sanitize with 70% Iso Propyl Alcohol solution. Collect the loose dust from floor using vacuum cleaner.
5.3 Preparation of 70% IPA solution
5.3.1 For preparation of 70% IPA take Warehouse officer/executive IPA and water in 70: 30 ratios.

E.g. for 100 ml of 70% IPA take the 70 ml of IPA and water for 30 ml.
5.3.2 Mention the record for preparation of 70% IPA as per Annexure -1.
5.3.3 Validity of freshly prepared 70 % IPA solution is 03 days.
6.0 Forms and Records
6.1 Freshly prepared 70% IPA Solution Record – Annexure -1
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Warehouse Department.
8.0 History