PHCbi Cleanroom Solutions

As a pioneering and world-respected manufacturer of medical and research equipment, PHCbi is able to offer incubation and cold storage solutions that are optimized to comply with specialized cleanroom environmental requirements that are becoming increasingly important as biologically derived technologies and products become ever more important in the pharmaceutical and life sciences industries.

To ensure that its equipment can be trusted as an essential tool for cleanroom applications, PHCbi has invested in the certification of its flagship cold storage and cell culture incubators to meets GMP standards by being ISO cleanroom classified by independent approved testing laboratories.

Cleanroom Classifications

A cleanroom is a controlled environment where the concentration of airborne particles like dust, microbes and aerosol particles are must be limited below defined levels. Cleanrooms must be maintained and operated in ways that minimize introduction, generation and retention of particles in the environment.

All cleanrooms that meet the GMP guidelines are classified according to the cleanliness level of the air inside them, with The International Organization for Standardization (ISO), having developed a range of classifications associated with the levels of cleanroom certification. ISO cleanroom designations are based on thresholds of defined size particles allowed within specified volumes (Table 1). GMP requirements stipulate that cleanroom classifications should be carried out according to ISO 14644-1. This ISO classification impacts every cleanroom user in the GMP community.

ISO-Certified Cleanroom Applications

Many laboratories and clinical facilities need cleanrooms for a variety of reasons. Contaminants or particles in the air greatly impact the process of both testing and manufacturing samples and products. The creation of particles by certain laboratory equipment can lead to accelerated degradation, contamination and total loss of biologically relevant material.

Seven of the top 10 best-selling drugs of 2019 were biologics (Table 2), whose manufacturing process guidelines stipulate that any change during the manufacturing process, regardless of how minor, may alter product quality and efficacy. Therefore, within GMP facilities, it is important to classify clean areas accurately. Furthermore, GMP compliance can only be achieved when consistent GMP-grade materials from well-characterized sources are implemented and utilized. Therefore one of the first steps in this process is implementing cleanroom certified furniture and equipment.

PHCbi Design for Cleanrooms

PHCbi understands that equipment not qualified for cleanroom settings can present a variety of hurdles in proper cleanroom maintenance. For example, uncertified tools and equipment with motors and other moving parts can introduce a reservoir of particles into the environment. Some essential equipment also incorporate motors and other devices that have a multitude of potential particles to shed.

PHCbi brand products have been carefully designed, engineered and constructed to fit seamlessly into any space or protocol. Engineered with cell health in mind, PHCbi brand MCO incubators have minimal moving parts and optimize decontamination protocols while minimizing contamination risks. Its ultra-low temperature (ULT) freezers are built with a unique sealed refrigeration system, coupled with a sealed bearing design on the cooling fans to reduce particle emissions.

PHCbi Cleanroom Solutions

There are four PHCbi solutions that are ISO-classified for cleanroom use:

• MCO-170AICUVH-PE: This 165-litre CO₂ Incubator provides precise control of carbon dioxide concentration and accurate, uniform, and highly responsive temperature control within the chamber. During cell culturing the inCu-saFe germicidal interior and SafeCell UV lamp work continuously to prevent contamination. Other features include feature data logging, LCD touchscreen display and USB connectivity. The MCO-170AIC features H₂O₂ Decontamination for easier sterilization in place (SIP) and meets ISO Class 5 Cleanroom standards.
• MCO-230AICUVH-PE: This IncuSafe CO₂ incubator also meets ISO Cleanroom Class 5 standards and incorporates similar features to the MCO-170AIC Series to provide precise control of CO₂ concentration and accurate, uniform, and highly responsive temperature control within the chamber, along with H₂O₂ Decontamination, inCu-saFe germicidal interior and SafeCell UV lamp work for continuous contamination control. The increased 230-litre capacity provides opportunities to use the incubator to scale up from R&D to clinical trials and manufacturing.
• MCO-80IC-PE: This large-scale cell culture IncuSafe CO₂ Incubator offers 830 liters of storage with a reach-in shelved format that is ideal for culturing high volumes of samples with optimum temperature and CO₂ uniformity throughout the chamber and rapid recovery after door openings with exceptionally low CO₂ gas consumption. The full view, double paned glass door allows easy observation of culture while the door heating system combined with specially designed air flow system prevents condensation throughout the cabinet. This unit meets ISO Class 5.5 Cleanroom standards.
• MDF-DU702VX-PE: This 728-litre TwinGuard ultra-low temperature (ULT) Freezer operates at between -50°C and -86°C for safe, long-term storage of biomedical samples and other high-value materials and meets ISO Class 6.0 cleanroom standards. It incorporates VIP PLUS vacuum insulation and TwinGuard dual independent refrigeration systems, combined with optional liquid CO₂ back-up system to offer unrivalled sample protection and security. The upright format offers multiple shelf configurations for flexible storage options, along with the intelligent color LCD touch panel interface combined with EZlatch door handle for full user control and easy access, even with gloved hands. It also incorporates a USB port for transfer of logged data to PC.

Testing Methodology

Each unit receives appropriate ISO CleanRoom classification after undergoing the following testing methodology:

1. Testing is performed in a dynamic environmental chamber with defined air, temperature, and humidity conditions.
2. Cleanliness of the chamber is calculated according to ISO 14644-14:2016.
3. Device is loaded in the chamber for 24 hours to find equilibrium before testing.
4. Particle count concentrations are then monitored for 120 minutes, with number of particles per cubic meter measured in size ranges of ≥ 0.1 μm, ≥ 0.2 μm, ≥ 0.3 μm and ≥ 0.5 μm in diameter.
5. Mean particle concentrations, upper confidence limit in the empty chamber and corresponding ISO Class ratings are then calculated and defined according to ISO 14644-1:2015.

Resources

Click on Cleanroom Classification for further information.
Click on Cleanrooms, GMPs and ISO Certification Application Notes to download brochure.