STANDARD OPERATING PROCEDURE SOP No MJ-64-02-012

Title : Revision No. 04

Superseded No. 03
Issue Date 28 November, 2023
OPERATIONAL PROCEDURE
Revision Due 27 November, 2026
REGARDING INHOUSE LAUNDRY OF
Page No. 1 of 5
CLEANROOM UNIFORM

Effective Date :

Owner of the SOP : HR & Administration

Cross Functional Area : Production Department, Injection Molding & Extruder Section, Sterilization
Section, Maintenance Section, Utility Section, Quality Control Inspection,
Quality Compliance, Quality Control Lab, Supply Chain Department

Name Designation Signature/ date

Prepared by S. M. Saiduzzaman Assistant Manager, HR & Administration

Muhammad Baki Billah Senior Manager, HR & Administration

Md. Sharifuzzaman Manager, Quality Control Lab

Checked by
Shamir Kumar Dey Manager, Quality Compliance
Md. Arfan Uddin Factory Manager

Approved by Kazi Mohammad Rafiqul Islam DGM, Quality Assurance

Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
 STANDARD OPERATING PROCEDURE SOP No MJ-64-02-012
Revision No. 04
TITLE : Superseded No. 03
Issue Date 28 November, 2023
OPERATIONAL PROCEDURE Revision Due 27 November, 2026
REGARDING INHOUSE LAUNDRY OF Page No. 2 of 5
CLEANROOM UNIFORM

1. PURPOSE
This operational procedure shall be applied to control inside laundry service of particle free
cleanroom uniform and to prevent the contamination of product during working period in NIPRO JMI
Company Limited, Vitikandi, Gazaria-1510, Munshiganj.

2. SCOPE
This operational procedure shall be applied to control laundry facilities for cleanroom uniform
which is used inside in the factory.

3. RESPONSIBILITIES
3.1 Laundry Service Operator is responsible for to receive uniforms to be washed and return
washed uniforms.
3.2 Responsible Management staffs of HR & Administration is responsible for ensuring
particle free cleanroom uniform and also control checklist of laundry service area in
NIPRO JMI Company Ltd.
3.3 In charge of HR & Administration is responsible for overall advisory, review & guidance of the
process.
3.4 Incharge of QCL is responsible for ensuring the microbiological free dress as per their
procedure
3.5 In charge of Quality Compliance is responsible for review of this SOP.
3.6 Factory Manager is responsible for editorial, review and guidance of the process.
3.7 In charge of Quality Assurance (QA) is responsible for review and approval of this SOP.

4. REFERENCES & CROSS REFERENCES

4.1 References : ISO 13485:2016 Medical Devices-Quality management systems
requirements for regulatory purposes.
4.2 Cross References
MJ-64-01-008 : Operational Procedure employees hand checking and gowning
monitoring
MJ-64-02-003 : “Operational Procedure on Uniform Wearing”
5. DEFINITION
N/A

6. ABBREVIATION, ACRONYMS AND SYMBOLS

N/A

7. PROCEDURE
7.1 Collection of uniform for washing service
7.1.1 Uniform user or section will submit their uniform in garment receiving zone in
present of HR & Admin person.
7.1.2 Store the used garments in the garment cabinets according to the dress number,
size and color-coding
7.1.3 Segregate the garments according to color code and store them in separate bags
and record the number of garments in the record for garment submission to a
laundry.
Send the collected garments to the in-house washing and drying with ironing
7.1.4
Facility.
7.2 Cleanroom items collection & distribution procedure:
7.2.1 Once cleanroom uniforms are washed, Dress distribution person will collect the
washed cleanroom uniforms
 STANDARD OPERATING PROCEDURE SOP No MJ-64-02-012
Revision No. 04
TITLE : Superseded No. 03
Issue Date 28 November, 2023
OPERATIONAL PROCEDURE Revision Due 27 November, 2026
REGARDING INHOUSE LAUNDRY OF Page No. 3 of 5
CLEANROOM UNIFORM

7.2.2 Every week Thursday every employees will submit their cleanroom items in the
designated container box or poly bag which will be placed at specific locations.
Record of Cleanroom dress cleaning and hanging will be maintained as per form
no. “Weekly Cleanroom items washing & Distributing sheet MJ-64-02-012F01”
7.2.3 In case cleanroom uniforms count is less, Dress distribution person should ensure
the reason regarding this issue If any discrepancy is noted, the dress distribution
person needs to inform responsible person of HR and the Admin handle the
discrepancy.
7.2.3 All washed cleanroom uniforms will display in cleanroom area
7.3 Procedure for washing and drying of garments:
7.3.1 Different color-coded garments shall be washed separately.
7.3.2 Number or amount of garment to be placed in the washing machine as per
validated load.
7.3.3 Once the washing is completed, a drying cycle shall be run to dry the garments.
Ensure that clothes are not in wet condition.
7.3.4 Once the garments are dried, they shall be unloaded and placed at a clean
uniforms area and dry properly by natural hits
7.4 Washing machine operating procedure
7.4.1 Check electrical line which is connected with machine properly
7.4.2 Every batch should be 15-20 uniforms (as applicable)
7.4.3 Each batch time should be 20-25 minutes (as applicable)
7.4.4 Take out when it is washed properly
7.4.5 Drying at outside or applicable dryer machine
7.4.6 Other than cleanroom uniform ironing will done from outside if required
7.5 Procedure for garment inspection and microbiological test
7.5.1 Washed and dried garments shall be inspected to ensure that they are not torn,
adequately cleaned, and do not have any stain or extraneous material (if required)
7.5.2 If any abnormality is observed, it shall be segregated for required correction.
7.6 Entry and exit procedure for entering and exiting from laundry room:
7.6.1 While working in the laundry room, personnel need to maintain the gowning to
prevent contamination of gown.
7.6.2 Entry restricted at Laundry premise unless prier permission from HR &
Administration Department.
7.6.3 Structural additions and alterations or repairs to the said laundry premises, repairs
to electric, water and sanitary installations, which may be found necessary from
time to time.
7.7 Prohibited Items
7.7.1 The placing of gloves, plastic raincoats, fluorescent vests, leather and suede
clothing for laundry service is prohibited.
7.8 Rewashing
7.8.1 If any uniform is found dirty then rewash will be required. If the spot/torn is
permanent then dress will be declared as rejected.
7.9 Laundry room area cleaning procedure:
7.9.1 Laundry room area cleaning or monitoring will be checked as per checklist “Daily
laundry room surface cleaning checklist MJ-64-02-012F02”
7.10 Cleaning procedure of laundry area:
7.10.1 Surface /Floor Cleaning:
7.10.1.1 Wipe down countertops and surfaces.
7.10.1.2 Clean the exterior of washing machines and dryers.
 STANDARD OPERATING PROCEDURE SOP No MJ-64-02-012
Revision No. 04
TITLE : Superseded No. 03
Issue Date 28 November, 2023
OPERATIONAL PROCEDURE Revision Due 27 November, 2026
REGARDING INHOUSE LAUNDRY OF Page No. 4 of 5
CLEANROOM UNIFORM

7.10.1.3 Clean Dust shelves and Sweep and mop the floor.
7.10.2 Appliance Maintenance
7.10.2.1 Clean lint traps in dryers.
7.10.2.2 Check and clean washing machine dispensers.
7.10.2.3 Inspect and wipe rubber seals on washing machines
7.10.3 Ventilation
7.10.3.1 Check and clean ventilation fans or filters
7.10.4 Safety Checks
7.10.4.1 Inspect electrical outlets and cords for safety
7.10.4.2 Ensure emergency exits are clear
7.10.5 Trash Disposal
7.10.5.1 Empty and clean trash bins
7.10 Washing procedure during machine problem/shut down
7.11.1 During maintenance or any shutdown situation of laundry machine we will provide
laundry facilities through alternating way like wash through physically like hand
wash
7.12 Preparation of Disinfectants
7.12.1 During washing time of uniforms through washing machine, first Laundry Service
Operator separate the hood and dress and then soak it into the water with
detergent as required.
7.12.2 To disinfectant the uniforms use bleaching powder (5gm with 05 liter water)
7.12.3 To ensure the uniforms is more free from visible dirt or contamination, use
Savlon/Dettol for getting maximum effectiveness
7.13 Pictorial Step of washing procedure as per attachment #01

8. FORMS/ATTACHMENTS
Form/Attachment Title
No.
Attachment#01 Pictorial Step of Washing Procedure
MJ-64-02-012F01 Weekly Cleanroom Items Washing & Distribution sheet
MJ-64-02-012F02 Daily laundry room surface cleaning checklist

9. REVISION HISTORY
Revision number Effective Date Reason for revision
29 November
00 First Time Issue
2012
As per CR Ref No. DC-HR-15H-009 (Update the
01 21 June, 2016
SOP as per internal audit observation MNC#04)
As per Change Control Ref No. DC-HR-17J-007
22 November, (Internal Audit observation MNC#06) exclude
02
2017 Quality Compliance checking option from form No.
MJ-64-02-012F01 as per actual practice.
As per Internal Audit Observation MNC#06, CAPA
23 Ref Number# NJMI/CA/20/J/007, Inclusion of
03
November,2020 Weekly Cleanroom Items Washing & Distribution
form & update the SOP.
STANDARD OPERATING PROCEDURE SOP No MJ-64-02-012
Revision No. 04
TITLE : Superseded No. 03
Issue Date 28 November, 2023
OPERATIONAL PROCEDURE Revision Due 27 November, 2026
REGARDING INHOUSE LAUNDRY OF Page No. 5 of 5
CLEANROOM UNIFORM

As per CR Reference number #

04 own laundry service has been established in the
factory