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sop for for Cleaning and Sterilization of Goggles

 

sop for for Cleaning and Sterilization of Goggles

 

1.0 OBJECTIVE:
1.1 To lay down the procedure for Cleaning and Sterilization of Goggles.
2.0 SCOPE:
2.1 This SOP is applicable to Cleaning and Sterilization of Goggles in Injection (Parenteral) Area
3.0 RESPONSIBILITY:
3.1 Officer / Executive – Production
4.0 ACCOUNTABILITY:
4.1 Head – Production
5.0 PROCEDURE:
5.1 Collect all sterile area Goggles in SS container and bring them to Unit preaparation.
5.2 Clean the goggles with purified water.
5.3 Clean the SS container using lint free mop with 70% IPA.
5.4 Using Lint free Mop and flush them with Purified Water till frothing disappears.
5.5 Keep the goggles in SS container.
5.6 Sterilize the goggles at 121.4°C for 30 minutes along with other accessories.
5.7 Open the door from sterile area and unload the goggles under Laminar Air Flow unit in cooling zone.

Then transfer them in sterile garment cabinet.
5.8 Record the cleaning and sterilization details of goggles in Annexure-I.
5.9 Record the details of goggles sterilization Cycles as per Annexure-II.
5.10 Sterilization cycles of goggles should not be more than 120. The goggles shall be discarded

after 120 sterilization cycles or in case of physical damages in presence of IPQA person.
5.11 Frequency: Daily



6.0 ABBREVIATION:

Sr. No. Abbreviation used Full form of abbreviation used
1. SOP Standard Operating Procedure
2. WFI Water for Injection
3. Ltd. Limited
4. No. Number
5. QA Quality Assurance
6. IPA Iso-propyl-alcohol
7. UV Ultraviolet Light

7.0 ATTACHMENTS (ANNEXES) :
Annex-I: Cleaning & Sterilization Record of Goggles
Annex-II: Sterilization Cycles Record of Goggles
8.0 REFRENCE:

In-House

Annex-I

CLEANING & STERILIZATION  RECORD OF GOGGLES

Department: Production                                                                                     Month / Year

Date Cleaning Period No. of Goggles Set Cleaned Done By

Sign & Date

Checked

By Sign & Date

Sterilization Period No. of Goggles Set Set Sterilized Done By Sign & Date Checked

By Sign & Date

From To From To
                     

 

Annex-II

STERILIZATION CYCLES RECORD OF GOGGLES

Department:                                                                                                                       Line:

Goggles I.D. No.:                                                                                            Date of Issuance:

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
Cycle 71 72 73 74 75 76 77 78 79 80
Done By

Sign & Date

Date
Cycle 81 82 83 84 85 86 87 88 89 90
Done By

Sign & Date

Date
Cycle 91 92 93 94 95 96 97 98 99 100
Done By

Sign & Date

Date
Cycle 101 102 103 104 105 106 107 108 109 110
Done By

Sign & Date

Date
Cycle 111 112 113 114 115 116 117 118 119 120
Done By

Sign & Date

Discarded & Destroyed on:

 

Reason

 

Sign/Date (Production)                                                                             Sign/Date (QA):

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