NSAI Dublin, 28TH APRIL 2016


There are still some places available for our workshop seminar. Please follow this link to book.

Due to the demand for knowledge and how to apply these new Classification and Monitoring standards the ICS and NSAI are delighted to announce a 2nd date for a workshop seminar on the changes and application of ISO 14644-1 & -2:2015.  

I am delighted to welcome back the 2 subject matter experts, Andre van Tongeren from the Dutch VCCN and Lene Blicher Olesen from Denmark and the R3 Nordic cleanroom society.

Notes from the 1st workshop seminar on February 25th

On February 28th last we had 30 attendees coming from cleanroom testers, design build contractors, Life Science vendors and Life Science GMP users.  The NSAI conference room was laid out in a 6 tables so 5 per table and with 3 display screens everyone was able to interact with each other and the 3 experts moved freely around the room to give guidance and answer questions. Andre van Tongeren is a Cleanroom Tester by profession in Holland and represented the Dutch cleanroom society, VCCN. Lene Blicher Olesen is Director of Vaccine Filling with the Statens Serum Institut in Denmark representing GMP Users and the Nordic cleanroom society, R3.  I represented cleanroom designers and the design of EM programmes. All 3 of us are subject matter experts in TC 209.  The discussions were detailed and lively covering mainly GMP issues. Topics ranged from the impact on Annex 1, issues in Cleanroom testing and monitoring, relationships to other standards in the ISO 14644 family, relationship between ISO 14698 and viable EM to -2:2015, Cleanroom design of Gown Rooms and Airlocks, the controversial removal of the 5 micron particle size in the classification table in -1:2015, how risk assessments in -2:2015 should be carried out, expectations from the HPRA and how and when the standards should applied.

Background Note

2016 is proving to be a big year for Cleanrooms with the introduction of ISO 14644-1 & -2:2015.   The latest and hopefully final draft international standard ISO FDIS 14644-3 on Metrology should come out for voting later this year.  This should pave the way for publication at the end of this year.  These are fundamental standards in Cleanrooms and should be followed by a significant revision of ISO 14644-4 on Design, Construction and Start Up of Cleanrooms.

ISO 14644-1 & -2:2015 was finally published on the 15th December 2015 - after 9 years of a working group, WG01 of TC209. 

Along with other national cleanroom and contamination control societies, the ICS is organising a practical application workshop seminar to introduce the updated standard with the assistance and contribution of other European national cleanroom society experts who were involved in WG01 or WG03.

Workshop Seminar

Date:                28/04/2016
Duration           1 day workshop seminar
Location:           NSAI , 1 Swift Square, Northwood, Santry, Dublin 9, Ireland D09 A0E4
Cost:                  €580 (for those who already have the 2 standards the cost will be €400).

Attendee fee includes notes, a hard copy or soft electronic PDF copy of ISO 14644-1:2015 and ISO 14644-2:2015*, refreshments and lunch.

* Combined value €146 + €84 = €230

NSAI Dublin Meeting & Hotel Information (512.4 KB)NSAI Dublin Meeting & Hotel Information (512.4 KB)

ISO 14644-1:2015 & ISO 14644-2:2015 SEMINAR PROGRAMME & WORKSHOP NOTES

The day will be broken into 2 parts - a technical seminar in the morning (09:00 - 11:30) and then a workshop in the afternoon (11:30 - 17:00) to show how to apply the new standard to existing cleanrooms. There will time for side bar discussions and breaks in the morning along with sit down lunch in the NSAI canteen with a short break in the afternoon.

Download the Seminar Programme:
ICS Workshop Seminar on ISO 14644-1 & -2:2015, NSAI (2.29 MB)ICS Workshop Seminar on ISO 14644-1 & -2:2015, NSAI (2.29 MB)

A key element of the day will be the afternoon workshop where individual experts will work with companies to give specific guidance on how to apply ISO 14644-1 & -2:2015 and update their own SoPs.

Download the April Workshop Notes: Workshop Notes (106 KB)Workshop Notes (106 KB)

The attendance will be restricted again to no more than 30 people and we expect the attendees on this occasion to come from companies involved in updating their SOPs in ongoing non viable monitoring and Cleanroom Commissioning, Qualification, Testing and Verification.

Booking is on a first come basis. Please follow this link to book.

On behalf of Andre van Tongeren, Lene Blicher Olesen and myself we look forward to seeing you there!

Conor Murray
ICS Chairman

Head of Delegation for Ireland at ISO TC209
Irish Subject Matter Expert ISO TC 209
WG 01 - Airborne Particle Classification
WG 04 - Cleanroom Design & Start Up
WG 13 - Cleanroom Energy Management
Convenor Biocontamination Working Group CEN TC243 (WG-05)
Convenor Irish Biocontamination Mirror Group
Convenor SC13 - Cleanrooms, Health Care Services Consultative (HCSC) Committee NSAI