Continuous Microbial Monitoring

Continuous Microbial Monitoring

Microbial Monitoring Tools

EU GMP Annex 1: Elevating Sterile Product Manufacturing Standards

Aseptic Sterile Manufacturing .The art of performing a specific sterile manufacturing process within an ultra clean cleanroom environment to ensure that the product’s such as an injectable solution is transported from bulk sterile containers and filled into vials, or syringes or capsules. Ensuring complete sterility of the product.

EU GMP Annex 1 States
Continuous viable air monitoring in grade A (e.g. air sampling or settle plates) should be undertaken for the full duration of critical processing, including equipment (aseptic setup) assembly and critical processing. A similar approach should be considered for Grade B cleanrooms based on the risk of impact on the aseptic processing. The monitoring should be performed in such a way that all interventions, transient events and any system deterioration would be captured and any risk caused by interventions of the monitoring operations be avoided.

How do you meet continuous viable air monitoring? The best way is to understand the technology we use and to select the right viable monitoring solutions. Check out this quick video to get an idea of how to monitor a BSC using particle counters, active air samplers and settle plates. ​

​“Annex 1 provides general guidance that should be used in the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying the principles of Quality Risk Management (QRM), to ensure that microbial, particulate and endotoxin/pyrogen contamination is prevented in the final product”.​

​Let us help you understand how you can meet Annex1 continuous viable monitoring requirements using existing technology that you may have without breaking the bank or having to revalidate your system.[link to webinar]

Active air sampling during aseptic processing is a critical requirement in Grade A cleanrooms. Key considerations include the physical and biological efficiencies of air samplers, appropriate flowrates, and HEPA-filtered exhausts. The goal is to maintain an environment with zero CFUs

Cost Reductions on 8 Hour Process

100L/min Flowrate

  • Media dish every 10 minutes
  • 48 media dishes every 8 hours
  • 336 per week (7 days)
  • 17472 media dishes per year
  • $52,416 cost per year
  • $262,080 per filling line
  • Labor costs per year $1.7m

25L/min Flowrate

  • Media dish every 40 minutes
  • 12 media dishes every 8 hours
  • 84 per week (7 days)
  • 4368 media dishes per year
  • $13,104 cost per year
  • $65,520 per filling line
  • Labor costs per year $699k

10L/min Flowrate

  • Media dish every 100 minutes
  • 5 media dishes every 8 hours
  • 35 per week (7 days)
  • 1820 media dishes per year
  • $5460 cost per year
  • $27,300 per filling line
  • Labor costs per year $291k