クリーンルーム規格（ISO 14644-1/2: 2015）に関する所見と解決策

粒子数測定情報　ISO 14644-1:2015 について

ISO 14644-1:2015規格は、クリーンルーム管理者および製造業者に依然として難題を突き付けています。ここでは、このISO規格に関する初心者から現場のベテランまで、誰にでも役立つ情報源を提供します。

下記の文書をお読みいただくか、右側に記録されたウェビナーをご覧いただくことで、ISO 14644-1:2015の規格に関する概要が理解できます。

ISO 21501-4準拠のキャリブレーション（校正）基準とその適用方法を学ぶには、下記の文書を読んでください。

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ISO 21501-4規格に準拠したキャリブレーション方法に対応するISO 14644-1:2015 適合製品をお探しですか？その場合は、下記の弊社製品一覧をご覧ください。

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ISO 14644-1:2015 Compliant Products
Supported by ISO 21501-4 Certified Calibration

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At Particle Measuring Systems we have strict processes and standards in place to ensure that we meet and exceed service and calibration standards such as:

ISO 21501-4:2007
ISO 9001:2008
ISO 17025
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Frequently Asked Questions

Can the Lasair II 550L be upgraded to be compliant with ISO 21501-4?

The Lasair II 550L cannot be upgraded to the new ISO certification requirements. This product has been obsolete since 2009 and it is recommended to upgrade to the fully compliant Lasair III. We can provide a quotation if you are interested in a new unit.

How does the recent Lasair III firmware update work with the EU GMP classification for Grade A areas with the corrected ISO standard?

EU GMP Annex 1 provides specific particle concentration limits for specific cleanroom classes (Grade A, B, C and D). The Lasair III Aerosol Particle Counter, when used with GMP statistical mode, will refer to the GMP maximum concentration table.

Does ISO 14644-1 apply to a solid dose facility?

Yes, ISO 14644-1 can be applied to this type of manufacturing area. You should verify which class and standard your cleanroom must be compliant with. ISO 14644-1 is applicable for any type of cleanroom, including Pharmaceuticals.

Has the new ISO had an effect on the number of the stationary particle counters (for monitoring) in a filling machine?

No, the number of continuous sample locations is not affected by the ISO14644-1. Monitoring control guidelines are available in the ISO14644-2 standards which clearly require a risk assessment based approach for the evaluation/selection of the sample location. Use this document for suggestions in selecting the best non-viable location for monitoring purposes.

No, the cleanroom monitoring cannot replace the classification test to be performed on annual or semi-annual base.

Also, the classification process dictated by the iso14644-1 must be performed in combination with the equipment/Hvac system test as per ISO14644-3.

The particle size must be determined according with your process and product requirements.

Generally, Pharmaceutical producer are required to monitor particles # 0.5 and 5 micron.

In Pharmaceutical industries, 5um particles are still required to be monitored in ISO class 5.

A risk assessment analysis is required to support the selection of specific particle sizes to be monitored.

ISO 14644 do not specifically talk about microbial contamination, but takes only care of particles. Anyway, microbial contamination must be controlled as well during production using appropriate monitoring tools. You can find additional details in the EU-GMP Annex 1, FDA cGMP and ISO 14698.

The sample height, or sample location, must be within 1 foot from the critical zone. The sample height must always be in proximity or equal to the work height.

Particle sample shall never be done just under the filter, unless during filter scanning test.

Several operating condition and performance should be monitored in cleanroom, again based on your specific process and product risk evaluation. The ISO list, but not limits to, parameters like temperatures, differential pressure, humidity, ventilation performance ….

CFR 21 part 11 dictate the requirement for the correct management of data. As part of batch release process, the data collected by any monitoring systems, shall be managed with appropriate software system or procedure in respect of the Data Integrity good practices and CFR 21 part 11 standard.

It’s recommended to define alert and action limit based on a consistent amount of data, typically 4 to 6 months trend provides a consistent and reliable picture to be used for limit set-up.

All standards, including ISO, GMP etc, always refer to cumulative particle.

Differential value can be used for investigation and troubleshooting purpose.

Yes, stainless steel 316L tubing can be used, as well as other material such as Tygon, Bev-a-line or Polyurethane.

It is important to select the tubing based on the adherence characteristics and strictly respecting the specific internal diameter size as specified by the manufacturer.

Unfortunately there are no answer to this question, because prior the ISO 21501-4 (2007), no ISO standard where existing for particle counter calibration and any instrument manufacturer were using his own procedure and method… limiting the harmonization and repeatability of measurements.

The instrument manufacturer must specify in the user manual or specification sheet which is the maximum allowed tubing length. In most case this is equal among different flowrate.

Your proposed approach is right. The grade B may be even be sampled prior the filling to verify the cleanliness of the area and suitability for the production operation.

In a monitoring scenario, I would recommend you to configure your particle counter to a series of 1-min samples. This method will provide you a better “real time” vision of any unexpected event.

You can start referring to the ISO 14644-1 Classification limits for your specific cleanliness class, and begin create your data trend as soon as possible.

No, you do not need to replicate the same sample location classified as per ISO 14644-1.

Most of the time the number of position per monitoring are less than half of the classification requirement.

The selection of monitoring sample location must be supported by a risk assessment.

ISO 14644 refer to the ISO 21501-4 for calibration requirement. This standard recommend the calibration to be done at least once per year or less.

Yes, this is a normal practices to ensure the flow cabinet is in the right cleanliness condition before starting the production process.

I also suggest you to evaluate the recovery time following the ISO14644-3 standard, in this way you can define how many minutes/hours you need to run the fan prior the production activities.

Absolutely yes. GMP guidelines refer to the ISO 14644 in many section, but without any specific revision number or release date. This always mean that the latest/actual version must be applied.

Anytime you read a GMP reference to the ISO standard, you need to consider the last version available (for this case, the 2015).

Unfortunately no, this kind of test will not provide any evidences of:

Counting efficiency
Size error
Resolution
Flow rate verification
Etc etc…..

All particle counter must be calibrated and “challenged” against a calibrated reference instrument (not an handheld device) in order to comply with the ISO 21501-4 standard

For classification process, you can define the number of sample location by referring to the table A.1 available in the ISO 14644-1:2015.

In case of monitoring, you need to develop an appropriate risk assessment in order to identify your critical location to be sampled.

クリーンルーム規格（ISO 14644-1/2: 2015）に関する所見と解決策

粒子数測定情報　ISO 14644-1:2015 について

Knowledge / Papers

ISO 14644-1:2015 Compliant Products
Supported by ISO 21501-4 Certified Calibration

PMS Provides Certified Compliant Service

Service Repair & Calibration

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クリーンルーム規格（ISO 14644-1/2: 2015）に関する所見と解決策

粒子数測定情報 ISO 14644-1:2015 について

Knowledge / Papers

ISO 14644-1:2015 Compliant ProductsSupported by ISO 21501-4 Certified Calibration

PMS Provides Certified Compliant Service

Service Repair & Calibration

製品情報

アプリケーション

サービス・サポート

ナレッジセンター

会社情報

Particle Measuring Systems

製品情報

アプリケーション

規格・規制

サービス・サポート

ナレッジセンター

会社情報

Particle Measuring Systems

粒子数測定情報　ISO 14644-1:2015 について

ISO 14644-1:2015 Compliant Products
Supported by ISO 21501-4 Certified Calibration