Considerations for contact plate recovery in cleanrooms
The study provides greater insight into some of the key factors that affect microbiological surface contamination in cleanrooms.
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The study provides greater insight into some of the key factors that affect microbiological surface contamination in cleanrooms.
This exclusive report addresses the key obstacles and innovations shaping pharmaceutical environmental monitoring, from QC and contamination control, to the impact of advanced technologies and regulatory changes. Discover practical solutions you can implement to drive progress for your organisation.
The approach offers key benefits such as facilitating a reduction in the risk of microbial contamination and reduction in the required air change rate in aseptic processing.
Addressing key challenges in the pharmaceutical and biotechnology environmental monitoring market, such as high technology costs, while leveraging key market drivers is critical for the sector to thrive, analysis suggests.
The research highlights a potential approach to address cross-contamination challenges during cell-processing operations.
The proposed technique outperformed traditional controllers, supporting improved air quality control in cleanrooms, according to the study.
Analysis cites personalised medicine, outsourcing and digitalisation as some of the key factors set to advance the pharmaceutical analytical testing market to 2032.
Gill Lewis, QP and Chief GMP Consultant, eXmoor Pharma. discusses the company's approach to environmental monitoring and the key challenges faced during integration at its Cell and Gene Therapy Centre in Bristol, a facility which received a GMP license from the MHRA in August.
Single-temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single-temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges…
Microbial air sampling in controlled environments should be performed isokinetically. The following text explains the isokinetic sampling process using MAS-100 instruments with a flow rate of 100 L/min and compares it with sampling at a lower flow rate of 25 L/min.
Three different contact plate methods were tested to determine a convenient manual surface sampling technique for microbial contamination recovery, the paper explained.
The type of clothing worn in aseptic manufacturing areas may impact the number of particle and airborne bacteria detected in biosafety cabinets.
With the outdoor environment being a primary contamination source in the pharmaceutical cleanroom, measures like good manufacturing practices (GMP) is key to reduce this risk, a paper asserts.
This report is dedicated to exploring some of the latest advances in pharmaceutical environmental monitoring, covering topics from contamination control and cleanroom validation through to emerging technologies for bacterial endotoxin testing.
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.