GMP-compliant equipment design must be qualified for GMP compliant and suitable for the manufacturing of medicinal products ...
GMP-compliant equipment design must be qualified for GMP compliant and suitable for the manufacturing of medicinal products. The design and technology used of a system makes a huge impact on the manufactured product that has to be sterile or is temperature or oxygen sensitive. One of the specifications apply to every GMP compliant equipment design in the GMP regulations is that the system must be easy to clean.
A direct heat COâ‚‚ incubator that better supports you and your science
Choice of either a 165 L (5.8 cu ft) or 255 L (9.0 cu ft) for a variety
of applications
Readily stackable in a compact footprint
Choice of electropolished stainless steel or 100% pure copper
Adjustable, perforated shelving
Easy-to-clean, coved-corner interior with convenient access port
Reversible exterior door for added flexibility
2 year parts and labor warranty
Cleaning validation with GMP compliance
A chemical cleaner or disinfectant may be appropriate for use on many surfaces but inappropriate for laboratory equipment, particularly which is usually heated and always immersed. Corrosion due to chemicals is exacerbated in a COâ‚‚ incubator for culturing cells derived from tissues because of the increased heat and humidity, especially because of the COâ‚‚ gas itself. COâ‚‚ gas readily dissolves in any liquid.
Hence, automated, on-demand systems for sterilization inside a COâ‚‚ incubator is critical with proven effective according to the standards in the U.S. and European pharmacopeias. Briefly, this includes proof of elimination of at least one million heat-resistant spores of the bacterium Bacillus subtilis (also known as Bacillus atrophaeus), the approved biological indicator organism for dry-heat sterilization and for vaporized hydrogen peroxide (VHP) sterilization. .
How to prevent cleanroom panel from being corroded in the VHP disinfection environment?
Specific to VHP systems, it is important to note that this chemical is toxic in high concentrations and that the U.S. Occupational Health and Safety Administration has set a permissible exposure limit (PEL) of 1 part per million (ppm) per 8-hour workday . For this reason, it is critical that any VHP process be proven effective and the chemical be proven neutralized at the completion of the process. Only a dry, noncondensing VHP system is recommended, where the humidity is carefully controlled. This is because if the VHP condenses into liquid, it can corrode equipment and materials over time. There are many suppliers offering VHP, and this term is applied to processes that include chemicals in addition to hydrogen peroxide, including peracetic acid, phenol, and acetic acid.We have seen several different VHP processes cause corrosion and therefore cannot recommend them.
Based on these considerations, our recommendation is to use the Thermo Scientific™ Steri-Run™ 180°C automated, high-temperature sterilization system for incubators even with 100% pure copper interiors Specific procedures are presented for cleaning and disinfecting the Thermo Scientific™ Heracell™ Vios™ CR and Thermo Scientific™ Forma™ Steri-Cycle™ CR CO2 incubators – CTS™ Series, which are certified as cleanroom-compatible. Procedure for cleaning and disinfecting a Heracell Vios CR or Forma Steri-Cycle CR CO₂ incubator can be found in attached application note.
2. What is a certified cleanroom-compatible CO2 incubator design, and why is this an important consideration for any cell therapy or gene therapy process? Smart Notes (thermofisher.com)
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GMP-compliant equipment design must be qualified for GMP compliant and suitable for the manufacturing of medicinal products ...
GMP-compliant equipment design must be qualified for GMP compliant and suitable for the manufacturing of medicinal products. The design and technology used of a system makes a huge impact on the manufactured product that has to be sterile or is temperature or oxygen sensitive. One of the specifications apply to every GMP compliant equipment design in the GMP regulations is that the system must be easy to clean.
A direct heat COâ‚‚ incubator that better supports you and your science
Cleaning validation with GMP compliance
A chemical cleaner or disinfectant may be appropriate for use on many surfaces but inappropriate for laboratory equipment, particularly which is usually heated and always immersed. Corrosion due to chemicals is exacerbated in a COâ‚‚ incubator for culturing cells derived from tissues because of the increased heat and humidity, especially because of the COâ‚‚ gas itself. COâ‚‚ gas readily dissolves in any liquid.
Hence, automated, on-demand systems for sterilization inside a COâ‚‚ incubator is critical with proven effective according to the standards in the U.S. and European pharmacopeias. Briefly, this includes proof of elimination of at least one million heat-resistant spores of the bacterium Bacillus subtilis (also known as Bacillus atrophaeus), the approved biological indicator organism for dry-heat sterilization and for vaporized hydrogen peroxide (VHP) sterilization. .
How to prevent cleanroom panel from being corroded in the VHP disinfection environment?
Specific to VHP systems, it is important to note that this chemical is toxic in high concentrations and that the U.S. Occupational Health and Safety Administration has set a permissible exposure limit (PEL) of 1 part per million (ppm) per 8-hour workday . For this reason, it is critical that any VHP process be proven effective and the chemical be proven neutralized at the completion of the process. Only a dry, noncondensing VHP system is recommended, where the humidity is carefully controlled. This is because if the VHP condenses into liquid, it can corrode equipment and materials over time. There are many suppliers offering VHP, and this term is applied to processes that include chemicals in addition to hydrogen peroxide, including peracetic acid, phenol, and acetic acid.We have seen several different VHP processes cause corrosion and therefore cannot recommend them.
Based on these considerations, our recommendation is to use the Thermo Scientific™ Steri-Run™ 180°C automated, high-temperature sterilization system for incubators even with 100% pure copper interiors Specific procedures are presented for cleaning and disinfecting the Thermo Scientific™ Heracell™ Vios™ CR and Thermo Scientific™ Forma™ Steri-Cycle™ CR CO2 incubators – CTS™ Series, which are certified as cleanroom-compatible. Procedure for cleaning and disinfecting a Heracell Vios CR or Forma Steri-Cycle CR CO₂ incubator can be found in attached application note.
Additional Resources
1. Procedure for cleaning and disinfecting a Heracell Vios CR or Forma Steri-Cycle CR COâ‚‚ incubator https://assets.thermofisher.com/TFS-Assets/LPD/Application-Notes/LPD-GPS-ViosCR-Cleaning-AppNote-Global-FWR.pdf
2. What is a certified cleanroom-compatible CO2 incubator design, and why is this an important consideration for any cell therapy or gene therapy process? Smart Notes (thermofisher.com)
3. EMBARK ON THE REMARKABLE CELL AND GENE THERAPY LABORATORY EQUIPMENT Cell and Gene Therapy Lab Equipment (thermofisher.com)
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