A course entitled. Particle counting to ISO Parts 1& 2

Transcription

1 A course entitled Particle counting to ISO 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 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 :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.

2 Course timetable Registration Definitions & DPC terminology Principles of operation of DPC ISO Classification of Air Cleanliness ISO Testing and monitoring to prove continued compliance EU Guidelines GMP Coffee Practical worked exercises The Validation Protocol Lunch Revision and questions Examination Part 1 Questions Examination Part 2 Validating a facility.

3 Course syllabus (Content of course notes) 1. Introduction General Definitions - Discrete particle counter (DPC) Terminology Particle Size Particle Concentration Sample Volume Sample Flow Rate Principle of Operation of the Discrete Particle Counter (DPC) Caution Operation Laser Light Exhaust Air Sizes Particle Size Volume Size DPC Air Flow Rates Particle Detection & Counting Unit Volume Reporting the Count Counting Efficiency Coincidence Counting Particle shapes and colour Comparison of Counts between two Particle Counters Practical Measurement Isokinetic Sampling Practical Measurement Clean Air Filter Sample Port Plug Good operating practices: DPC Calibration BS EN ISO F Family of Cleanroom Standards BS EN ISO Classification of Air Cleanliness Classifications currently undertaken by equation Informative Sections Occupancy States... 23

4 Customer Relations with the Tester Preparation for Testing Reporting Sampling Establishing the Sample Locations Minimum single sample volume at each location Sample Probe Location Working Plane Determining particle size for the required ISO Class EU Guidelines GMP Annex Manufacture of Sterile Medicinal Products Sample Data Determining if the Facility meets the Designated Cleanroom Class Treatment of 95% Upper Confidence Limit Data BS EN ISO Part Practical Exercises Basic Test Requirements for Non-Sterile 1 Ampoules Suite Basic Test Requirements for Change Room Sample Locations Variances to Standard Documented Location Positions for the Change Room Single Sample Volume Number of Samples per Location Mark Out measuring points Setting up the DPC Taking the Measurements Start Sampling Moving around the Cleanroom Analysing and Presenting the Data Recorded Data Example Validation Protocol Validation Objective Standard Operating Procedures... 45

5 8.3 Particle Counting Method Statement Test instrumentation Facility Overview Facility Drawings Variances to ISO Recorded Data