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Customer

An Italian CMO pharmaceutical company that produces and sells sterile products worldwide

Customer Challange

This pharmaceutical company wanted to improve the environmental monitoring system used in the aseptic filling production line to:

• reduce risk of possible contamination while improving quality control
• obtain immediate identification of any microbiological contamination
• reduce aseptic interventions
• improve root-cause investigations
• reduce production stops while increasing production capability

The currently used systems for environmental monitoring are not real-time. They are based on Light Scattering Particle Counters and Microbiological Impactors that use Petri dishes. The Petri dishes need to be changed once every 2-4 hours and placed in incubation to obtain a response. This method poses quite a few problems:

• Manage hundreds of Petri dishes every month.
• Changing Petri dishes means stopping the production line. Each change takes around 15 minutes so in an 8-hour day the production line stops for 2 hours.
• As the response comes only after 3-5 days of incubation, the production line might already be contaminated and the products might not be suitable for sale.
• The isolator needs internal space to stock Petri dishes, and space inside an isolator is limited.

These issues brought the customer to look for an alternative, and they contacted Comecer, their supplier of isolation technology. They required an isolator that would continuously monitor microbiological contamination of viable particles inside an aseptic isolator.

This alternative solution would help viable and non-viable continuous monitoring without the need for Petri dish substitutions, require a limited sample point space, and provide an important improvement in production efficiency and quality.

Comecer Approach

Comecer approached QS Group, a provider of contamination control products, and they jointly investigated the potential of integrating the Biotrak system in the isolated aseptic filling line.

Comecer found Biotrak to be a good opportunity:

• Biotrack is a 3-in-1 instrument for particle and microbiological monitoring in real-time (in compliance with ISO 21501-4, ISO 14644, and GMP) in pharmaceutical manufacturing environments.
• Biotrack performs continuous, real-time LIF (Laser Induced Fluorescence) counting of airborne microorganisms.

Comecer performed a Quality Risk Assessment for the Biotrack system and the integration feasibility. Mechanical and electrical integration was also addressed on the existing isolated filling machine.

Solution Highlights

Complete software and hardware integration of Biotrak technology.

Redesign of filling machine technical area to install Biotrak instruments in a different location next to the sample points.

Innovative Comecer aseptic filling under isolator with Biotrak advantages.

Solution Advantages

• Continuous manufacturing improvement: 24×7 without interruption.
• It is a true ISO 21501-4:2018 particle counter with a viable detector and possible gel incubation for quality control.
• No need for Petri dishes and for a dedicated plate-changing operator, saving time and money.
• Biotrak notifies you in real-time if the product is exposed to contamination and corrective action can therefore be taken immediately.
• The solution can be fully validated by IQ-OQ-PQ.
• QSGroup specialists create and perform IQ/OQ/PQ protocols.
• The product is well known and the manufacturer has almost 40 years of experience in this field.