We are pleased to announce that we are holding an Open House for our Itasca Pharmaceutical Center of Excellence Expansion on Thursday, June 22 from 8:30 am – 7:00 pm. This event will include a free one-day seminar Critical Considerations in Parenteral Product Testing at our Nelson Labs Itasca facility, located just outside of Chicago.
Breakfast, lunch, and snacks will be provided. Please RSVP if you plan to attend the Full Day (seminar, lab tour, networking) or if you plan to attend the Open House Only (lab tour and networking).
Seminar: View the agenda
8:30 am – 3:30 pm
- Microbiological Testing & Sterilization
- Parenteral Packaging: Container Closure Integrity Testing (CCIT) for Sterile Barrier Packaging
- A Systematic Approach to Extractables & Leachables
- Developing a Contamination Control Strategy
- Phase Appropriate Method Validation
- Terminal Sterilization for Drug Products
Open House
3:30 pm – 7:00 pm
- Stop by anytime between 3:30 pm – 7:00 pm us for a guided lab tour and networking
- Beverages and snacks will be available
- Participants can join after the seminar or come for the open house only
Course highlights are listed below.
Introduction to Microbiology & Sterilization
This session will cover a number of topics including microbial characterization and interpretation of data, with some case studies and discussion. We will also talk about sterilization concepts and sterilization of parenteral products, USP vs ISO approaches and test methods including rapid sterility testing, and selection of sterility assurance levels with how it impacts product and patients. Lastly, we’ll talk about single-use systems in pharma/biopharma manufacturing and assess the means of verifying sterility of the systems.
Speaker: Martell Winters, BS, RM/SM (NRCM), CISS-RAD, Director of Scientific Competency
Nelson Labs
Container Closure Integrity Testing (CCIT) for Pharmaceutical Sterile Barrier Packaging
CCIT testing is used to evaluate pharmaceutical packaging, such as vials, syringes, auto-injectors, and IV bags for sterile barrier integrity breaches. This presentation will review all the common CCIT methods found in USP <1207> to compare the testing options. Jen will explore CCIT method validation approaches as well as pitfalls to enhance understanding of how methods can be applied to different sample types.
- Deterministic vs. probabilistic methods (why choose one over the other)?
- How do the different methods work?
- How do you set up a validation for a CCIT method?
- What are some pitfalls to avoid during the validation?
Speaker: Jennifer Gygi, B.S., SM(NRCM), CBA(ASQ), Expert Technical Consultant, Packaging
Nelson Labs
A Systematic Approach to Extractables & Leachables Studies
This presentation will review best practices, including case studies, and provide a systematic approach to extractables and leachables in accordance with PQRI (Product Quality Research Institute), BPOG (Biopharm Operations Group), and/or USP General Chapters <1663> and <1664>. Aryo will address the various phases of extractables and leachables testing including:
- Controlled extraction studies
- Model extraction studies
- Leachables method development and validation studies
- Leachables studies in support of stability
This presentation is an excellent opportunity for individuals involved in analytical development, formulation development, and/or manufacturing to expand their knowledge and develop an optimal approach for extractable and leachable in support of containers/closures for Drug Products.
Speaker:Aryo Nikopour, VP Global Pharma Segment
Nelson Labs
Developing a Contamination Control Strategy
Annex 1 of the EU GMP now requires the creation of a Contamination Control Strategy (CSS). This presentation will focus on developing a CSS—how to identify and assess risk, prepare mitigation pathways, and define preventive actions associated with contamination in sterile product manufacturing.
Speaker: Sue Schniepp, Distinguished Fellow
Regulatory Compliance Associates (RCA)
Board of Director’s Chair
Parenteral Drug Association (PDA)
Phase Appropriate Method Validation
The method validation of analytical procedures used to assess the quality of drug substances and drug products is required by regulatory agencies to be “fit for their intended purpose”. Consequently, many pharmaceutical companies have different interpretations of the regulations and may side with a conservative approach to validation (e.g., validation of many or all attributes). However, if time and cost are a concern, designing a phase-appropriate analytical development and validation strategy can be essential to the success of a small or virtual pharmaceutical company. Phasing analytical validation offers a cost-effective risk mitigation strategy generally accepted as fit for use at each stage of development. This talk will provide an overview of phase-appropriate validation and propose the validation attributes at different stages of development.
Speaker: Dr. Kareem Chehade, CEO
KEHI Consulting Company
Terminal Sterilization of Drug Products
Abstract coming soon.
Speaker: John Schlecht, VP Technical Consulting Services
Sterigenics
