9 – 10 May 2023: Cleanroom and Associate Controlled Environment

Cleanroom and Associate Controlled Environment

9 -10 May 2023

2 full days

Hybrid – Select from Classroom Training (Hotel)  or Online Training (Zoom)

8.30am – 5.30pm

Eastin Hotel Penang

Online Training will be via Zoom.


Controlled and certified cleanrooms are essential in the medical devices industry when sterilisation is part of the  manufacturing process. Cleanrooms are highly controlled environments, where air contaminants level are controlled and certain physical and microbiological requirements need to be met. Without effective control, contamination can wreak havoc on the products and processes. As medical devices broach into higher risk category, control of airborne particles and surface contamination becomes a constant challenge. This leads to manufacturing facilities leaning towards a higher cleanroom level classification then the bare minimum to future proof their built. Good cleanroom practices will have a significant impact on the quality of products being produced and the processes performed in the cleanroom. The internationally recognised standards on cleanroom and its associated environments; ISO14644 and ISO14698 are both specifically reference in the ISO13485 2016 for work environment and contamination control where it categorically states that organisation are required to maintain the necessary cleanliness during assembly or packaging.



Participants will be introduced to the principles and methodology of air cleanliness classification in cleanrooms, the prerequisite and optional tests, changing room best practices with reference to the standard, implementation of the standard’s specified requirements during operation and an understanding of biocontamination, principals for its control and monitoring. The followings with reference to the ISO 14644 and ISO 14698 are covered:

• Airborne contaminants measurement and cleanroom classification;
• Mandatory test, supportive tests and monitoring of cleanrooms performance;
• Cleanroom Validation overview – built stages, occupancy state and qualification stages;
• Changing room control, configuration and facilities;
• Maintaining operational cleanliness;
• Biocontamination sampling for control/ monitoring.


  • Classification of air cleanliness by particle concentration
  • Monitoring to provide evidence of cleanroom performance
  • Cleanrooms test methods (sampling of supporting tests)
  • Overview of cleanroom design, construction and start-up
  • Cleanroom operations and control practices.
  • Formal system and biocontamination monitoring.



At the end of the session, participants will;

  • Gain a practical perspective understanding on cleanrooms control and practices.
  • Be knowledgeable on the monitoring of cleanrooms performance to the standard’s requirements.
  • Be aware of the requisite requirements of cleanrooms which reflect current “state of the art”.


This programme is designed for all levels and functions of an organization who needs to gain operational practical knowledge and desires to be compliant with regards to the ISO requirements on cleanroom and its associated environments in practice with reference to:

  • ISO 14644-1: 2015 Cleanroom and associated control environment: Classification of air cleanliness
  • ISO 14644-2: 2015 Cleanroom and associated control environment: Monitoring
  • ISO 14644-3: 2019 Cleanroom and associated control environment: Test methods
  • ISO 14644-4: 2022 Cleanroom and associated control environment: Design, construction and start-up
  • ISO 14644-5: 2004 Cleanroom and associated control environment: Operations
  • ISO 14698-1: 2003 Cleanroom and associated control environment: Biocontamination control

This is a hybrid training course – you may select Classroom Training (Hotel) or Online Training (Zoom). The organiser reserves the right to switch to full online training by giving due notice to the registered participants.

Sign up for more than 6 pax, and enjoy special Group Registration Fee and Bonus Deal.

Course Fees – for 2 days Classroom Training
Online Training
Early Bird Course Fees (Registration by 17 April 2023) RM (inc 6% SST) RM (inc 6% SST)
AMMI Member                 1,590.00  1,272.00
Non Member                 1,802.00   1,484.00
Normal Course Fees  (Registration from 18 April 2023 onwards)
AMMI Member                 1,802.00    1,484.00
Non Member                 2,014.00 1,696.00
Package Deals
Group Registration > 6 pax                 1,484.00  1,166.00
Bonus Deal (9th – 18 pax)                    530.00 212.00


Option 1: HRD Corp Claimable Course Scheme

A quotation together with course outlines and course agenda will be sent to you for HRD Corp grant application upon confirmation of the training. Please send us the grant application number for our record upon submission.

Option 2: Self-paying

2a) Direct Bank-in or via E-Banking

An invoice will be sent to you within 3 working days upon your registration. Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice. Please email us (admin@medsociate.com) the bank-in slip / remittance slip once the payment is made.

Please refer the following bank account details:
Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 230-302-078-2
Bank: UOB Bank
Swift Code: UOVBMYKL

For Government Sector –
A Local Order (LO) or letter of approval to participate must be submitted before your registration can be confirmed.

2b) Direct Online Payment
You may choose to make credit card payment via Paypal. An invoice with payment link will be sent to your email address separately when you choose this option.

The organisers, AMMI/Medsociate Sdn Bhd reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded in full if the cancellation is made by AMMI/Medsociate Sdn Bhd. No shows and cancellations made by participants/ companies within the specified period will incur the specified costs as per below schedule.


Prior to Training Date Cancellation Charges
30 days or more  No charges
15-29 days 25% of training course fee 
8 – 14 days 50% of training course fee
0 – 7 days 100% of training course fee


Replacement of participant is allowed at no additional cost if you are unable to attend. Please inform us of the replacement in writing at least 3 working days before the training date.

For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI

Email: admin@medsociate.com

Tel: +6010 4040 662