A course entitled

“Particle counting to ISO 14644 Parts 1& 2”

Summary
The course is called ‘Particle Counting to ISO 14644: Parts 1 and 2’. The course
lasts one day.

The course is for people who are required to classify cleanrooms according to ISO
14644 Parts 1 & 2, or to supervise the people who carry out the classification. This
course concentrates on the correct theoretical use of Discrete Particle Counters
(DPCs) and a simulated practical application of the data obtained from DPCs to
accurately classify a cleanroom.

Candidates are only accepted into the course if they have at least 1 year’s
practical experience in cleanroom validation, and have some mathematical
awareness and familiarity with statistical calculations.

On registration, the candidate receives a set of self-study course notes, and an

example of an exam paper. Prior to attending the course, the candidates are
sent a marking schedule, which clearly identifies how the practical simulation
examination is marked and what is expected from them. The candidates must
study the course notes, and then attend a one-day lecture course and
examination.

The 2 part examination consists, firstly, of a number of questions about particle

counting, 65% of which must be answered correctly to pass the course. The
candidate must then write a validation report for a cleanroom suite using
drawings of the suite and previously obtained DPC data as per ISO 14644-
1:1999, paragraph 4.4.

The overall pass mark is 55% but candidates who achieve a pass mark of 75%,
or greater, will be awarded a ‘Merit’ pass. Successful candidates are entered
onto the list of successful candidates that is held on the ICS Internet site. This
is linked to the ICEB internet site. This registration applies to the person who
passes the exam, and not their company. Certified persons will remain
registered for 5 years, after which time they must be re-certified by resitting the
examination.
Course timetable

0800- 0900 Registration

0900-1030 Definitions & DPC terminology

Principles of operation of DPC
ISO14644-1 Classification of Air Cleanliness
ISO 14644-2 Testing and monitoring to prove continued
compliance
EU Guidelines GMP

1030-1100 Coffee

1100-1230 Practical worked exercises

The Validation Protocol

1230-1315 Lunch

1315 –1400 Revision and questions

1400- 1430 Examination Part 1 Questions

1430-1630 Examination Part 2 Validating a facility.

Course syllabus (Content of course notes)

1. Introduction............................................................................................................... 5
2. General..................................................................................................................... 6
3. Definitions - Discrete particle counter (DPC) Terminology........................ 8
3.1. Particle Size.....................................................................................................
8
3.2. Particle Concentration ..................................................................................... 8
3.3. Sample Volume................................................................................................ 8
3.4. Sample Flow Rate ........................................................................................... 8
4. Principle of Operation of the Discrete Particle Counter (DPC)....................... 8
4.1. Caution............................................................................................................. 8
4.1.1. Operation ........................................................................................................ 9
4.1.2. Laser Light ...................................................................................................... 9
4.1.3. Exhaust Air
10
4.2. Sizes ..................................................................................................... .......... 10
4.2.1. Particle Size............................................................................................ ....... 10
4.2.2. Volume Size.............................................................................................. . .. 11
4.3. DPC Air Flow Rates.................................................................................... . .... 11
4.4. Particle Detection & Counting .................................................................. ....
12
4.4.1. Unit Volume .................................................................................................. 13
4.4.2. Reporting the Count....................................................................................... 13
4.4.3. Counting Efficiency ........................................................................................ 14
4.4.4. Coincidence Counting.................................................................................... 15
4.4.5. Particle shapes and colour ............................................................................ 16
4.4.6. Comparison of Counts between two Particle Counters................................. 16
4.4.7. Practical Measurement – Isokinetic Sampling............................................... 17
4.4.8. Practical Measurement – Clean Air Filter ...................................................... 17
4.4.9. Sample Port Plug........................................................................................... 17
4.4.10. Good operating practices:..............................................................................
17
4.5. DPC Calibration ................................................................................................. 17

5. BS EN ISO 14644 F Family of Cleanroom Standards ............................................. 22

5.1. BS EN ISO 14644 – 1 Classification of Air Cleanliness .................................. .. 22
5.1.1. Classifications currently undertaken by equation .......................................... 22
5.1.2. Informative Sections ...................................................................................... 22
5.1.3. Occupancy States.......................................................................................... 23
 5.1.4. Customer Relations with the Tester .............................................................. 23
5.1.5. Preparation for Testing .................................................................................. 23
5.1.6. Reporting ....................................................................................................... 24
5.1.7. Sampling ........................................................................................................ 25
5.1.8. Establishing the Sample Locations................................................................ 25
5.1.9. Minimum single sample volume at each location .......................................... 26
5.1.10. Sample Probe Location – Working Plane......................................................
26
5.1.11. Determining particle size for the required ISO Class ..........................
27
5.1.12. EU Guidelines GMP – Annex 1 2009 – Manufacture of Sterile
Medicinal Products 28
5.1.15 Sample Data .......................................................................................
29
5.1.14 Determining if the Facility meets the Designated Cleanroom Class ...
30
5.1.15 Treatment of 95% Upper Confidence Limit Data................................
30

6 BS EN ISO 14644 Part 2.......................................................................................... 30

7 Practical Exercises ........................................................................................ 32

8.1 Basic Test Requirements for Non-Sterile 1 Ampoules Suite............................ 33
8.2 Basic Test Requirements for Change Room.............................................................34
8.3 Sample Locations ..................................................................................................... 35
7.3.1 Variances to Standard ................................................................................. 36
7.3.2 Documented Location Positions for the Change Room ................................ 36
7.3.3 Single Sample Volume .................................................................................. 36
7.3.4 Number of Samples per Location .................................................................. 38
7.3.5 Mark Out measuring points............................................................................ 38
7.3.6 Setting up the DPC........................................................................................ 38
7.3.7 Taking the Measurements ............................................................................. 38
7.3.8 Start Sampling ............................................................................................... 39
7.3.9 Moving around the Cleanroom ...................................................................... 39
7.3.10 Analysing and Presenting the Data ...............................................................
39
7.3.11 Recorded Data Example................................................................................ 40

8 Validation Protocol .................................................................................... 45

8.1 Validation Objective ............................................................................ 45
8.2 Standard Operating Procedures .................................................. 45
8.3 Particle Counting – Method Statement .........................................................................
45
8.4 Test instrumentation ..........................................................................
46
8.5 Facility Overview.................................................................................................... 48
8.6 Facility Drawings..................................................................................................... 48
8.7 Variances to ISO 14644-1 ...................................................................................... 50
8.8 Recorded Data............................ ............................ ............. 50