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