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):