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Cleaning and Filling of Isopropyl Alcohol Bottles

 

Cleaning and Filling of Isopropyl Alcohol Bottles

 

1.0 OBJECTIVE:
1.1 To lay down a procedure for Cleaning and Filling of Isopropyl Alcohol Bottles.
2.0 SCOPE:
2.1 This SOP is applicable for Cleaning and Filling of Isopropyl Alcohol Bottles used in Injection  Parenteral  Area
3.0 RESPONSIBILITY:
3.1 Officer / Executive – Production
4.0 ACCOUNTABILITY:
4.1 Head – Production
5.0 PROCEDURE:
5.1 CLEANING & FILLING OF IPA BOTTLES TO BE USED IN NON ASEPTIC AREA.
5.1.1 Isopropyl Alcohol Bottles shall be cleaned with Purified Water, if required using brush.
5.1.2 Finally rinse the Isopropyl Alcohol Bottles with Water for Injection.
5.1.3 The Isopropyl Alcohol Bottles shall be allowed to air dry.
5.1.4 Finally mop the dried Isopropyl Alcohol Bottles with 70% IPA from outside.
5.1.5 After cleaning, area supervisor shall check the Isopropyl Alcohol Bottles for satisfactory cleaning.
5.1.6 After satisfactory cleaning fill the Isopropyl Alcohol in IPA Bottles.
5.1.7 Record the cleaning details in “IPA Bottles Cleaning and Filling Record” as per format shown in Annexure-I.
5.1.8 Frequency: Daily

5.2 CLEANING & FILLING OF IPA BOTTLES TO BE USED IN ASEPTIC AREA.

5.2.1 Isopropyl Alcohol Bottles for Aseptic area shall be cleaned with purified water followed by



WFI, if required brush shall be used for cleaning.
5.2.2 Then Isopropyl Alcohol Bottles shall be allowed to air dry and then sterilized.
5.2.3 After sterilization of IPA Bottles Filling area person shall be fill filtered Isopropyl Alcohol in Bottels.
5.2.4 Prepare IPA Status Label as per format shown in Annexure-IV.
5.2.5 Only 80 sterilization cycles are permissible for a set of IPA Bottles, after completion of 80 cycles bottle shall be destroyed.
5.2.6 Record the cleaning and sterilization details in Annexure-II.
5.2.7 Record the details of IPA bottles sterilization Cycles as per Annexure-III.
5.2.8 Enter the detail of IPA Bottles ID No. shown in Annexure-V.
5.2.9 IPA bottles ID generated as each set shall be consist of 8 alphanumeric characters (4 alphabets, 1 separator & 3 numeric).
For Example: PIIPAB- 0001
PI: Injection (Parenteral)
IPAB: Isopropylalcohol Bottle
– : separator
0001: Represent the Serial Number
6.0 ABBREVIATIONS:

Sr.No. Abbreviation used Full form of abbreviation used
1. SOP Standard Operation Procedure
2. WFI Water for Injection
3. Ltd. Limited
4. No. Number
5. QA Quality Assurance.
6. IPA Isopropyl Alcohol

7.0 ATTACHMENTS (ANNEXES) :
Annex-I: IPA Bottles Cleaning and Filling Record
Annex-II: IPA Bottle Cleaning and Sterilization record
Annex-III: Sterilization Cycle Record of IPA Bottles
Annex-IV: 70 % IPA Solution for Hand Sanitation
Annex-V: List of IPA bottles

8.0 REFERENCES:

1. In-House

Annex-I

IPA BOTTLES CLEANING AND FILLING RECORD

   Department:                                                                                              Frequency: Daily

Date Area Cleaning Done By

Sign & Date

IPA Filled By

Sign & Date

Checked By

Sign & Date

From To
             

Annex-II

IPA Bottle Cleaning and Sterilization record

Department:                                                                                                   Frequency: Daily

Date Area Cleaning

time

    Done  By

Sign & Date

 

Sterilization time Done  By

Sign & Date

 

Checked By

Sign & Date

From To From To
                 

 

Annex-III

Sterilization Cycle Record of IPA Bottles

Department:                                                                                                                              Area:

IPA Bottles I.D. No.:

Date
Cycle 1 2 3 4 5 6 7 8 9 10
Done By

Sign & Date

Date
Cycle 11 12 13 14 15 16 17 18 19 20
Done By

Sign & Date

Date
Cycle 21 22 23 24 25 26 27 28 29 30
Done By

Sign & Date

Date
Cycle 31 32 33 34 35 36 37 38 39 40
Done By

Sign & Date

Date
Cycle 41 42 43 44 45 46 47 48 49 50
Done By

Sign & Date

Date
Cycle 51 52 53 54 55 56 57 58 59 60
Done By

Sign & Date

Date
Cycle 61 62 63 64 65 66 67 68 69 70
Done By

Sign & Date

Date
Done By

Sign & Date

71 72 73 74 75 76 77 78 79 80

Annex-IV

70 % IPA Solution for Hand Sanitation

70 % IPA SOLUTION FOR HAND SANITIZATION

 

Date & Time of  Preparation
Valid Up To    
Prepared by (Sign & Date)
Checked by (Sign & Date)

Annex-V

List of IPA bottles

S. No. Location IPA Bottle ID No.
     

Note: These IPA bottles shall be used in Aseptic area only.

 

Prepared By                                             Checked By                                                           Approved By

Officer/Executive                                  Manager Production                                                     Head QA

Sign & Date                                              Sign & Date                                                            Sign & Date

 

 

 

 

 

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