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