Biotechnology and Pharmaceutical Cleanroom Testing

Biotechnology and Pharmaceutical Cleanroom Testing

There are many different types of industries that use cleanrooms, so what makes a cleanroom in one industry different than another? It’s quite a common question. Let’s have a look at the different cleanroom industries in more detail along with varying ISO requirements.

Many biotechnology and pharmaceutical cleanrooms are specified at ISO Class 5 to ISO Class 8 and apply to a large portion of the cleanroom standards. If you’re not familiar, ISO classes and standards are set by the International Organisation for Standardisation.

clean-room-testing

The many ISO standards provide various requirements, specifications, guidelines and characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their intended purpose.

In all cleanrooms, particulate matter is a great concern. Specifically, viable particulate contamination should receive careful consideration and attention. Viable particulate contamination refers to the ability to keep the room clean by typically using modular or stick-built components with integral cove bases and corners, as well as coved ceilings in order to maintain a cleanable surface condition. This high grade finish is crucial for biotechnology and pharmaceutical cleanroom standards.

In all instances concealed areas may allow for bacterial growth which is unacceptable. These clean rooms typically use cleanroom technology that keeps the seal unbroken during sanitation and filter changes. Biotechnology and pharmaceutical cleanrooms typically have a heavy focus on pressurisation control, the elimination of cross contamination and the ongoing filtration of outdoor air and indoor air.

We undertake a wide range of clean room testing service for the Biotechnology and Pharmaceutical industries such as:

  1. Filter installation leak testing– Your ventilation system’s high efficiency particulate air (HEPA) filter, and its housing will be tested with DOP (Dispersed Oil Particulate) to ensure their integrity.
  2. Particulate testing – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process,
  3. Air supply and extract quantities– If your air supply is unidirectional we will measure and record the air velocity, while for non-unidirectional systems we will measure air supply.
  4. Differential pressure– Here we will be testing to ensure that the air in your clean room always moves from clean to less clean areas, with your clean room having a higher pressure than adjacent less clean areas.
  5. Containment leak testing– We will check the construction of your clean room to ensure that no airborne contamination can occur via leaks from higher pressure work areas adjacent to it.
  6. Air movement control– Studying the movement of the air within your clean room we will check that there is sufficient air movement to dilute or remove pollutants, preventing any contamination build-up.

Particulate-Testing-Cleanrooms

APT Cleanroom Testing provides clients with a reliable and proactive clean room testing service. If you would like to know more about our particulate testing service and/or  HEPA filter testing service to cleanrooms, please don’t hesitate to contact us at:  info@airpressuretesting.net

The Importance of Cleanroom Particle Testing

The Importance of Cleanroom Particle Testing

Clean room facilities such as Semiconductor and pharmaceutical manufacturers are examples of environments that require extensive and detailed air monitoring and periodic certification.  An accurate air monitoring and testing system is the only method for these clean room facilities to maintain that level of cleanliness needed during environmentally sensitive production.

In Jan 2016, ISO introduced an update to standards ISO 14644-1:2015 – Classification of air cleanliness by particle concentration and ISO 14644-2:2015 and monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.

APT Cleanroom Testing have received many questions in regards to what impact the updated standard has on validation and testing frequency. To try and help our clients we have tried to answer those questions here.

It is essential that your undertake clean room particle testing to prove it complies with ISO 14644-1:2015 – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process.

Clean Room Particle Testing 

Cleanroom-Particle-Testing

Within ISO 14644-2:2015 – Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration; recommends customers to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual cleanroom processes.

It states the maximum time interval between airborne particle concentration testing for  cleanrooms of ISO class 5 and below at six months and ISO class 6 and above at 12 months.

Cleanroom Particle Testing Software 

cleanroom-testing

Using our vast technical knowledge we provide our clients with reliable and proactive clean room testing service. We ensure that we provide accurate and thoroughly document clean room testing results, ensuring optimal cleanroom performance and minimised facility down time.

If you would like to know more about our particulate testing service to cleanrooms or our full clean room testing services, please don’t hesitate to contact us at:  info@airpressuretesting.net  or call Darren direct on 07775623464.

How often should I undertake Cleanroom Particle Testing

How often should I undertake Cleanroom Particle Testing 

In January 2016, ISO introduced an update to standards ISO 14644-1:2015 – Classification of air cleanliness by particle concentration and ISO 14644-2:2015 and Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.

Cleanroom-Particle-Testing

APT Cleanroom Testing have received many questions in regards to what impact the updated standard has on validation and testing frequency. To try and help our clients we have tried to answer those questions here.

It is essential that your undertake clean room particle testing to prove it complies with ISO 14644-1:2015 – Classification of air cleanliness by particle concentration. This ensures that your cleanroom continues to perform efficiently and enhance your ongoing business process,

Within ISO 14644-2:2015 – Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration; recommends customers to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual cleanroom processes.

clean-room-testing

It states the maximum time interval between airborne particle concentration testing for  cleanrooms of ISO class 5 and below at six months and ISO class 6 and above at 12 months. Here is a quick table showing this in more details.

Test Parameter Class Maximum Time Interval
Airborne particle concentration ISO Class 5 and below     6 months
ISO Class 5 and above

 

    12 months
Schedule of additional tests
Airflow velocities in unidirectional airflow All classes> 6 months
Airflow volume supply in non-unidirectional airflow All classes 12 months
Pressure differentials All classes Continuously monitored

Using our vast technical knowledge along with our commitment to quality we provide our clients with reliable and proactive clean room testing service. We ensure that we provide accurate and thoroughly document clean room testing results, ensuring optimal cleanroom performance, documented regulatory and quality compliance, and minimised facility down time.

If you would like more information on our clean room testing please contact APT Cleanroom Services at info@airpressuretesting.net or call Darren direct on 07775623464.