Accuracy Today. Welcome!! In This Issue. Contact Us. Newsletter Date: April 2015 Revision 1.0

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Maurice Lloyd
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Sample Locations Classification Interval Welcome!! Welcome to the first publication of the 2015 edition of Accuracy Today.

1 Accuracy Today Newsletter Date: April 2015 Revision 1.0 In This Issue Sampling with Isokinetic Probes CI-302 High Pressure Diffuser Update New Wireless Portable Particle Counters Problems with Plastic Enclosures Regulatory Updates o o o 5 µm Monitoring Sample Locations Classification Interval Welcome!! Welcome to the first publication of the 2015 edition of Accuracy Today. In our newsletter we try to inform our readers of quality control issues, changes in regulatory standards, and other matters that may impact their monitoring procedures, and overall quality control. In all industries, especially the Life Science sector, environmental monitoring of both inert and viable particles is a mission critical application. Accuracy, repeatability, reliability, and return on investment are important; and so is the mitigation of risk from a loss of business continuity, harm to business reputation, FDA fines, and plant closures. Furthermore, there are substantial hidden costs associated with deviation reports, which often result in considerable man-hours spent doing investigations. Over the coming year, we hope to bring you a number of informative articles that will hopefully provide greater insight into the world of environmental control and monitoring. Sampling with Isokinetic Probes By Randy Grater, Technical Services Manager Contact Us sales@climet.com +1 (909) Isokinetic (meaning constant velocity) sampling is the method used by particle counters to determine cleanroom particle concentration levels. Isokinetic probes are recommended to ensure a laminar flow of air into the particle counter, thus mitigating turbulence. Additionally, there are various models of Isokinetic probes which are geometrically different depending on the flow rate of the particle counter. Using the incorrect sample probe with a particle counter will result in over or under sampling, which will lead to inaccuracies. So, the first rule is to use the proper sample probe with the applicable flow rate of the particle counter. According to some sources, isokinetic sample probes should only be used in unidirectional (e.g., laminar) airflow systems. ISO 5 (Class 100) and cleaner facilities rely on unidirectional, or laminar, airflow. Laminar airflow means that filtered air is uniformly supplied in one direction (at a fixed velocity) in parallel streams, usually vertically

Therefore, one might presume that sample probes are only needed in these environments. However, this is not what ISO/DIS 14

2 Therefore, one might presume that sample probes are only needed in these environments. However, this is not what ISO/DIS states. Section C recommends setting the sampling probe inlet facing into the predominant direction of the airflow when deployed in a laminar flow. In locations where the airflow being sampled is not controlled or predictable (non-laminar), the inlet of the sampling probe shall be directed vertically upward. Therefore, an interpretation of Annex C reveals that isokinetic probes should be used in most, if not all cleanroom applications regardless of whether the air flow is laminar or uncontrolled. Some of our pharmaceutical customers have tried to eliminate the problem associated with >5 µm tubing loss by using a portable particle counter with a bare inlet. Without a sample probe, turbulence surrounds the inlet causing large particles to be deflected away from the sample probe, unless it falls straight into the inlet. Moreover, even without the turbulence, large particles that belong to the sample have too much inertia to be pulled over to the inlet, and would float past the inlet. The isokinetic probe entrains the large particles that belong to the sample into the inlet. Additionally, fluorescent lights can cause false high counts when sampling with a bare inlet. This is because the light turns on-and-off at a frequency that mimics particles passing through the laser beam. The isokinetic light blocking probe solves this problem. Other best practices when sampling in the Life Science industry is to ensure a maximum transport tube length of 10 feet (3 meters) is used (Per ASTM F50-12, and Federal Standard 209E). For 100 LPM (liter per minute) particle counters, Climet recommends 6.5 feet (2 meters) maximum. This is in agreement with ISO/DIS , Annex C. Furthermore, bends in the transport tubing should have a minimum radius of 15 cm (5.9 inches) per ASTM F By not following this guideline, one will experience a higher than normal >5 µm particle loss as these macroparticles are susceptible to tubing loss. When ordering a particle counter, Climet customers can choose between the standard Isokinetic Probe (by default) or the Isokinetic Light Blocking Probe (shown here), which fits directly onto the inlet

CI-302 High Pressure Diffuser Update Climet s CI-302 high pressure diffuser is designed to sample high pressure air and gases.

In response to customer inquiries, further testing has been performed that confirms we can support pressures up to 150 psi (1034 kpa) with selected versions of the CI-302.

New Wireless Portable Particle Counters Climet offers Wi-Fi portable particle counters in all flow rates. The two models are CI-x55 and CI-x56. The CI-x56 version has an added USB port.

3 CI-302 High Pressure Diffuser Update Climet s CI-302 high pressure diffuser is designed to sample high pressure air and gases. It is used with both our portable particle counters and microbial air samplers. In response to customer inquiries, further testing has been performed that confirms we can support pressures up to 150 psi (1034 kpa) with selected versions of the CI-302. Moreover, its new quite design eliminates high-pitch noise often experienced in the legacy CI-301 models. New Wireless Portable Particle Counters Climet offers Wi-Fi portable particle counters in all flow rates. The two models are CI-x55 and CI-x56. The CI-x56 version has an added USB port. Unique about the Climet wireless technology is automatic upload of sample data to a user-defined location on the network. This auto upload feature occurs immediately at the conclusion of each sample. If sample data is collected while the particle counter is out of wireless range, the instrument will automatically upload once the wireless connection is reestablished. By eliminating the need for human intervention, Climet has eliminated the potential for human error. Moreover, sample data is transmitted in a human readable CVS (Comma Separated Value) format, and is stored in a network directory made secure by the policies enforced by the network administrator. If using a Laboratory Information Management System (LIMS), the built-in scripting language can be set to upload the raw data for immediate processing. No additional software is required. Climet's wireless particle counters can be synchronized to a network timeserver. The timestamps on the samples imported can now be precise, and the risk of an analyst collecting data with a bad timestamp is eliminated. When purchasing one or more wireless particle counters, users will need to purchase either a wireless configuration kit, or a router kit. The former allows the unit to connect to an existing wireless network, while the router kit includes the equipment to establish a new wireless network

Problems with Plastic Enclosures Many astute cleanroom managers, especially from the pharmaceutical and biotechnology sectors, are well aware of the problems caused by instruments with plastic

4 Problems with Plastic Enclosures Many astute cleanroom managers, especially from the pharmaceutical and biotechnology sectors, are well aware of the problems caused by instruments with plastic enclosures. The problems are largely due to the significant and substantial risk these devices contribute to the inert particle burden of the cleanroom, as well as potential viable biocontamination. Contrary to the marketing hype, plastics (including thermoplastics such as polycarbonate) are neither durable nor are they rugged, especially if the instrument is portable or handheld. To the contrary, they are highly susceptible to accidental impact damage, which often results in micro-fractures, cracking, and splintering. In addition to releasing inert particles during the impact, the resultant damage creates perfect hiding places for bacteria, virus, and other viable microorganisms. Innocuous or innocent looking scuffs when magnified (see above) show scratching and abrasions that make sanitization difficult to impossible. Moreover, as can be seen, microfibers are created that are quite literally attached by the end of a hair. Any attempt to clean or scrub this area would likely result in detachment and an increase in particles including macroparticles > 5 µm. Plastics are also susceptible to biodegradation from ultraviolet light, moisture (e.g., cleaning solutions), bacteria, enzymes, and wind. During the biodegradation process microfractures, cracking and general disintegration occur; these make perfect hiding places for bacteria and other contaminates, as well as slowly releasing inert particles into the environment. ISO states: A.3.2 Selection for a particular application should consider, as a minimum, the following: i) sampler properties such as: 5) ease of cleaning and disinfection or sterilization, and 6) possible intrinsic addition of viable particles to the biocontamination to be measured

5 Portable and handheld instruments will be accidentally dropped, scuffed, scratched, and overall abused. A plastic enclosure, when compared to stainless steel, is a soft and fragile material that will no doubt contribute to the particle burden of a clean area when used as an enclosure for portable or handheld applications. Given what we know about the physical and chemical properties of plastics, when taken in the context of those regulations provided in the ISO standards, one can quickly conclude that plastics are a better fit in Indoor Air Quality (IAQ) investigations, and not cleanrooms subject to ISO or GMP regulations. Regulatory Update AS MANY ALREADY KNOW, THE ISO 14644:1999 STANDARD IS IN THE PROCESS OF BEING UPDATED. AS THE ISO/DIS HAS NOT BEEN RATIFIED. THE FOLLOWING IS PROVIDED FOR INFORMATION ONLY. 5µm Particle Limit in ISO Class 5 One of the main areas of concern, especially in the Life Science industry, is ISO Class 5 concentration limits for the >5 µm channel, which apparently is being de-emphasized. It is Climet s view that the >5µm particle count in the Life Science industry will remain important for Life Science monitoring and certification. Yes, the draft standard also leaves the metaphorical door open to 5 µm classification. An article about this subject is available on our website: Increase in Sample Locations Required for Classification With regards to the increase in sample locations, the 1999 revision of ISO used an equation to determine the number sample locations for classification: Where NL = the number of sample locations, and A is the square meters of the cleanroom. This equation is no longer used in the ISO/DIS The justification for the change is to provide at least 95% confidence that at least 90% of all locations do not exceed class limits. Instead, Annex A, Table A.1 (provided in the following pages), contains the required number of sample locations for a given area measured in square meters. The current number of sample points under ISO 14644:1999 for a 10 m x 10 m cleanroom is 10 locations. According to ISO/DIS this same area would require 16 sample locations for classification. Given the increase in sample locations one might reasonably expect the cost of interval cleanroom certifications to increase given the increase in - 5 -

labor. However, certifications made without consideration of the 5 µm concentration limit will substantially reduce sample times per the equation below.

6 labor. However, certifications made without consideration of the 5 µm concentration limit will substantially reduce sample times per the equation below. ** V S = Single Sample Volume per location (measured in liters) C n, m = The class limit (number of particles per cubic metre) for the largest considered particle size specified for the relevant class. ISO , Annex C refers to macroparticles >5 µm, and at the current time this section is an area of some debate. If the 5 µm particle size is no longer used in cleanroom validations for the Life Science Industry in ISO Class 5 areas, then this could have a significant impact on sample times used for certification. Sample times would be reduced to the regulatory minimum of 1 minute using a 1 CFM or higher flow rate particle counter. Note: Classification and monitoring are two different activities ** Footnote (f) refers to ISO/DIS , Annex C. This does not eliminate 5 µm classifications where there are specific process requirements. ISO/DIS is in harmony with EU GMP, Annex 1 (e.g. Pharmaceutical, biotechnology & Life Science) - 6 -

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Classification Interval Change The current classification interval for ISO 14644-2:1999 is provided on the table shown here. ISO/DIS 14644-2.1 no longer has this table.

This frequency can be extended based on risk assessment, the extent of the monitoring system, and data that are consistently in compliance with accepted limits or levels in the monitoring plan.

8 Classification Interval Change The current classification interval for ISO :1999 is provided on the table shown here. ISO/DIS no longer has this table. It states: Periodic classification testing shall be undertaken annually. This frequency can be extended based on risk assessment, the extent of the monitoring system, and data that are consistently in compliance with accepted limits or levels in the monitoring plan. Firmware & Software Revision Updates For customers who require previous firmware versions, or information about prior revisions, you can create a login to our website at: Suggestions, Comments & Recommendations We are always looking for relevant topics, and welcome your comments, suggestions, and feedback. Please contact: Jim Strachan, Sales and Marketing Manager JStrachan@climet.com

When Quality Matters. Microbial Air Samplers: Selection Criteria in Biopharma Manufacturing. Celebrating Over 50 Years In Business!

When Quality Matters. Microbial Air Samplers: Selection Criteria in Biopharma Manufacturing. Celebrating Over 50 Years In Business! When Quality Matters Celebrating Over 50 Years In Business! Microbial Air Samplers: Selection Criteria in Biopharma Manufacturing Rev. 1.0 (Jan 2016) 1 Doc No.: TN-160104-1 Printed: January 4, 2016 Copyright