Airborne Particle Counts

Particle counts are tested in all sorts of cleanroom environments using ISO 14644-1 (2015) as a fundamental basis for sample and location requirements. EU GMP and ISO 14644-1 share many similarities when it comes to cleanliness levels however, cleanroom ISO standards have the over-riding table when it comes to determining locations, based on room area (m²).

It is a necessity for ISO Class 4-9 and Grades A-D in EU GMP to monitor performance levels. Airborne particle counters provide vital information for maintaining indoor air quality in healthcare facilities. Our particle counters monitor the contamination level in the facility by measuring the quantity of airborne particulate at the time of testing. It then becomes important to monitor your controlled environment to determine that the area is capable of maintaining cleanroom classifications. This is best achieved by monitoring in the ‘at rest’ and ‘operational’ phases. At Saakvee, we offer service contacts and can work with your user requirement to develop a monitoring program.

Contact sales@saakvee.group to discuss developing a monitoring program

Airflow Readings

Air volume and velocity tests ensure unidirectional zones are maintaining proper air flow patterns and that flow areas (unidirectional and non-unidirectional) are achieving the correct volume for the desired air change rate. This is considered the primary test in cleanroom validation. The air change performance is considered at the cleanroom design qualification phase and is fundamental to ensuring that your controlled environments achieve their potential.

The test also helps the cleanroom’s effectiveness in preventing the transfer of contamination generated within that area.

HEPA Filter Integrity Testing Or DOP Testing

Filter integrity testing is conducted in line with ISO 14644-3:2019 and used to ascertain the filter integrity of an ULPA or HEPA filter.This involves introducing challenge aerosol steadily into the upstream flow of the filter media and scanning its downstream at the filter face,or in a duct, using a calibrated photometer. ULPA filters are rated at 99.9995% at 0.12-micron efficiency, while HEPA filters (H13/H14) are rated at 99.95%/99.995%. Fan filter units, or FFU’s use ULPA filter media and can have direct aerosol injection.

Contact sales@saakvee.group to discuss your cleanroom application and how we can assist your validation programme.

Air Pressure Differential

Pressure differentials are an important part of a cleanroom’s design and help to control contamination and other particulates.

Within a positively pressurised cleanroom, the most important room will have the highest pressure to keep sources of contamination away from the product. A negative room within a cleanroom facility might need to contain the product if it’s considered harmful. Either way, pressurisation is an important step in cleanroom validation.

A controlled environment may need to be re balanced to conform with the customer user requirement. At Saakvee Technologies, we can balance your cleanroom facility to create the correct pressure differential to suit your requirements.

Our independent instruments will be compared with your pressure displays to confirm accuracy and all of our test reports come with calibration certificates as standard.

Please contact sales@saakvee.group for more information

Air Changes And Volumes

The air change rate test is used to calculate the number of times an exchange of air occurs within the cleanroom per hour. The air change rate per hour (ACR/HR) calculates the total airflow supplied or extracted to, or from, the cleanroom, as well as measuring the overall volume of the cleanroom. It’s an important factor to help maintain the cleanroom classifications in the later testing phases

Contact sales@saakvee.group to discuss your cleanroom’s air change rate requirements

Containment Leak Test

This is undertaken in line with ISO 14644-3:2019 and is used to ensure there is no airborne contamination in the cleanroom, through leaks from nearby higher pressure areas within the facility. This test is usually carried out at commissioning but ISO 14644-2 suggests it should be carried out every four years, or after any significant change to the airflow system or equipment content.

Smoke Visualisation Testing

This test is carried out in line with ISO 14644-3:2019 and is a requirement at commissioning and thereafter every 4 years or after significant change to the airflow system or equipment. Most cleanroom’s will have some sort of change over this 4-year period, so it’s a good idea to factor in this procedure.

Cleanroom factors, such as positioning of equipment, can have a big effect on air movement and air flow patterns can be disrupted. The test can provide a useful visual aid to the best performing areas in your cleanroom and also areas that may need to be monitored more frequently. At Saakvee Technologies, we can provide testing that’s either witnessed or record evidence of airflow patterns and distribution.

Please contact sales@saakvee.group for more information

Safety Cabinet Assessment

Saakvee Technologies offers testing and maintenance services for Class I, II and III Bio-safety cabinets to ensure maximum protection. This includes KI Discuss testing and Fume Cabinet Testing. Carbon Breakthrough Testing in line with BS7989 is also available.

Recovery Rate Testing

The purpose of a recovery rate test is to see how quickly cleanroom classifications return to their required limits following a short period of contamination. It is deigned to mimic ‘wort-case scenario’ relating to the performance of the cleanroom being exposed to contamination.

This is performed to ISO 14644-3:2019 specifications and measures the recovery rate and recovery time of a cleanroom upon contamination. Test particles are introduced into the cleanroom, while the recovery time is sourced from measuring the time taken for the concentration of airborne particles to decay by a factor of 100:1 or 10:1, depending on cleanroom ISO standards or EU GMP Grade. The recovery time is usually set at 15 to 20 minutes but this a cleanroom guidance only.

Please contact sales@saakvee.group for more information

Ambient Comfort Tests

These tests are considered to be temperature, humidity, light and noise level. It’s now increasingly important to not only maintain comfort level for the operator, but to sustain an environment that’s suitable for your product.

Temperature and humidity levels can play an important part in maintaining cleanroom compliance. If they’re too high or low, they can also effect the airflow pattern.

Although they’re not considered as a validation frequency requirement, it’s important to monitor these factors at base level and should be considered during the design qualification phase.

Provision Of Particle Counter Calibration Certificates

ISO 14644–1:2015 specifies that each instrument should have a valid calibration certificate. Particle counter calibration certificates are expected to indicate compliance with ISO 21501-4:2007. This measures the uncertainty in flow rate, counting efficiency, size resolution, error and other required standards. A calibration certificate is always issued following monitoring of a cleanroom, no matter the performance outcome.

At SAAKVEE our particle counters are 21 CFR, part 11 compliant and you can rest assured knowing that all your historical particle count data will be backed up on our systems for future proofing.

Please contact sales@saakvee.group to discuss particulate counts and routine testing

Servicing And Maintenance

Saakvee Technologies offers comprehensive maintenance services for Cleanrooms and Cleanroom equipment. Our maintenance services cover various aspects, such as HVAC servicing, Fume Cabinet servicing, laminar flow servicing, local exhaust ventilation servicing, Bio-Safety Cabinet servicing, downflow servicing, Filter replacements and periodic cleaning.

Regular maintenance and servicing procedures help ensure Cleanroom compliance. Contact us today for your scheduled and emergency Cleanroom maintenance and repair services.

Extra Guaranty

Saakvee Technologies offers 24-hour support services and extended warranty for facilities using our Cleanrooms. We can come in for tests and validation any time our services are required; we also carry out periodic checks and maintenance on all our Cleanrooms. This can be conducted during client work time, without disturbing or disrupting workflow. Our exceptionally brilliant engineers are trained to work with minimal distractions to your normal industrial activities.

Saakvee Technologies are the best there is, and we promise you the very best service possible. Contact us today for validation of your Cleanroom and to take advantage of our extra guarantee.