Work Environment SOP

1. PURPOSE

This procedure describes the requirements for maintaining the work environment needed to achieve and maintain product
and service conformity within Manufacturer Quality Management System (QMS).

2. SCOPE

This procedure is applicable to the work environment of Manufacturer, which can include but not limited to the business
offices, manufacturing and storage spaces. If any of the processes are outsourced, the contract manufacturers and/or
critical suppliers must be able to demonstrate conformity to the environment required by Manufacturer.

3. RESPONSIBILITIES

The Production Engineer is responsible for the proper control and maintenance of the work environment within
Manufacturer, outsourced contract manufacturers and/or critical suppliers.

4. REFERENCE DOCUMENTS

ISO 13485: 2016

21 CFR 820 etc

5. DEFINITIONS

Work Environment: This includes all environments that could affect the quality of the products and services, not limited
to office, manufacturing and storage spaces.

6. PROCEDURE

6.1. Controls of Work Environment

Relevant work instructions are made accessible and in a simple to understand manner for the staff to ensure efficient and
consistent operations in their respective work areas. The staff has to read and understand the relevant user/equipment
manual and ensure compliance with these instructions. The supervisors’ and managers’ role is to make sure everyone
performing the procedures is adequately trained.

When some of the activities are outsourced to contract manufacturers or are performed by critical suppliers, the
environmental requirements have to be checked at least once a year via an audit.

Below are some examples of the various type of work environment and can be used as a stepping-stone to write the
detailed work instructions:

 Cleanroom – Class 1K, 10K or 100K cleanroom, depending on the stringency of the particle counts allowed for
the manufacturing activities of the medical devices. A Class 1K cleanroom is designed to never allow more than
1000 particles (0.5 microns or larger) per cubic foot of air. Class 10K and Class 100K cleanrooms are designed to
limit particles to 10,000 and 100,000 respectively. Refer to ISO 14644 for further references to cleanroom
classification and requirements.
 Laboratory – Some may require BSL-1 to BSL-4 cabinets to perform a certain level of work. Certain activities
require stringent temperature controls while some require DNAse or RNAse-free workspace.
 Temperature or Relative Humidity Controls – Production or storage environment for medical devices that are
temperature or moisture sensitive. E.g. - 20°C or 4°C storage rooms.
 Electrostatic Discharge (ESD) Protected Area – All conductive materials are grounded, workers are grounded,

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and charge build-up on ESD sensitive electronics is prevented.

Based on the above types of working environment, the staff will have to follow the recommended personal protective
equipment (PPE) and instructions before entering the premises. E.g., before entering a cleanroom, the gowning, cleaning
of hands and entering the air shower room are the few requirements that all staff have to follow.

6.2. Contamination Control

Manufacturer will plan and document the control of contaminated or potentially contaminated products in order to prevent
contamination of the work environment, staff and/or the product in the respective work instructions.

For sterile medical devices, apart from documenting the requirements for controlling the contamination of microorganisms
or particulate matter, Manufacturer will also provide information to maintain the required cleanliness during assembly or
packaging processes through the work instructions.

Some examples that could help with contamination controls are:

 Clearing of the production line before starting next production lot,

 Performing health checks and when the operator is sick, he/she is not allowed to enter the production area,
 Process validation of cleaning method, assembly, packing and sterilisation,
 Proper segregation of contamination product and normal product,
 Conduct tests such as agar plate test and bioburden test.

6.3. House-keeping

General housekeeping within the premises of Manufacturer is maintained regularly in order to promote a conducive and
safe working environment for everyone.

7. ATTACHMENTS

NIL

This is the end of the document.

Author: Production Engineer representing Production department.

DCR No. Version No. Author Reviewer Approver Implementation Description of

Date Change
01 Production Production QA/ RA Initial Release
Engineer Manager Manager

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