Lunch & Learn Seminars

Rapid Microbiology
Learn the benefits of implementing rapid microbiology for monitor-ing microbial contamination in raw materials, inprocess materials and non-sterile finished products at your facility. The technology and applications of the Milliflex® Quantum will be highlighted. The presentation will also discuss how to evaluate different rapid microbiological methods and develop your own user requirement specification (URS).

Sterility Testing
Review current sterility testing regulations and guidelines, industry issues and applicable future regulatory changes. Our experts will pre-sent an overview of a range of sterility test methods and lead a discus-sion on the critical aspects of sterility test components, highlighting a basic review of validation requirements. Practical solutions and helpful tips will be offered, based on decades of experience in sterility testing.

Aseptic Process Simulations - The Media Fill
Our experts will review the regulations and guidance for compliance with manufacturing and quality control, which will demonstrate the guaranteed sterility of your product, personnel and procedures. We will discuss the design of a media fill and the impact that a positive result can have on your company. We will also present the benefits of granulated dehydrated culture media.

Pyrogen Testing
Review the current pyrogen testing solutions and regulations, industry trends and applicable future regulatory changes. Our experts will present an overview of pyrogen testing, with a concentration on the Monocyte Activation test, a validated alternative method to the Rabbit Pyrogen test. Engage in a discussion on the critical components of the MAT test, review of requirements and helpful tips.

Microbial Limits Testing
Take a look at current Pharmacopeia require-ments and potential updates or changes. The impact of microbial contamination on drug production will be discussed along with the various test methodologies available today for microbial limits. Discussion will include validation requirements and how to perform microbial limits tests.

Non-Sterile Microbial Control
Our experts will review the new USP <63> for Mycoplasma to help you understand how this chapter will be enforced. Review of the Ph. Eur. 2.6.7 Nucleic Acid section will also be conducted as an alternative method for Mycoplasma detection. They will also go through a brief demonstration of our MilliPROBE System for detecting Mycoplasma.

Environmental Monitoring
Review the regulations and guidelines for microbiological monitor-ing of air. Air monitoring is a critical component of the environmental monitoring program of any pharmaceutical, biotherapeutic or medi-cal device manufacturer as well as a Good Manufacturing Practice (GMP) requirement for both the US and Europe. The key aspects of an environmental monitoring program will be highlighted along with the distinguishing features of various methodologies and validation requirements.