Recommended Practices for Manual Aseptic Processes

April 18, 2013 | 8:30 a.m. – 4:00 p.m.
PDA #216 | ACPE #0116-0000-12-216-L04-P | 0.6 CEUs
Type of Activity:  Knowledge

Course Description

The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile. For large scale automated operations, where operator interventions are infrequent, the verification of the ability to produce sterile product is evaluated by the conduct of large scale automated media fills in a manner analogous to normal production.

Processes using all or partial manual procedures must also be evaluated by process verification testing. However, such manual operations present unique operational and evaluation challenges not generally encountered with automated operations. While manual aseptic processes rely heavily on individual operator proficiency, operational personnel and their activities are generally recognized as the greatest source of potential microbial contamination during manual aseptic processes. Reproducible human performance cannot be assumed over time.

These and other challenges posed by manual aseptic processing must be considered when designing the evaluation protocol.

This course will provide valuable practical insights into the technological challenges associated with designing, operating and evaluating manual aseptic processing. Participants will come away with an understanding of how manual aseptic processes differ from automated ones, and what should be addressed as they work with manual aseptic processes in their own plants. They will also learn how process simulation testing to evaluate manual aseptic processing operations should be designed and carried out. Topics such as personnel training and qualification, design of manual aseptic processes and evaluation of manual aseptic processing process simulations will be covered. The course is based on a PDA Technical Report addressing the same subject.

Who Should Attend

This course will be of value to operational personnel who design, carry out and evaluate manual aseptic processing, including personnel involved with compounding, filling, packaging, and quality assurance operations. Support staff, such as engineering and validation personnel, will also benefit. The course will be suitable for supervisors and managers as well as personnel engaged in manual processing operations.

Learning Objectives

Upon the completion of this course, you will be able to:

• Discuss the challenges associated with manual aseptic processing
• Describe the elements involved in the design of process simulation studies for manual aseptic processing
• Explain the elements associated with training and qualification of personnel involved with manual aseptic processing
• Explain the differences to be considered when designing manual aseptic processing operations in unidirectional air flow and in isolators
• Apply the lessons learned to the design and conduct of manual aseptic processing operations to your job
• Design a protocol for the conduct of a process simulation test for manual processing

Instructor

Carol Lampe 

Registration Fees

Steam In Place

April 18, 2013 | 8:30 a.m. – 4:00 p.m.
PDA #313 | ACPE #0116-0000-12-313-L04-P | 0.6 CEUs
Type of Activity:  Application

Course Description

This course will enable participants to better understand how design and operational concepts can be applied to optimize (e.g., shorter more lethal cycles) steam in place cycles and also how to apply the most applicable validation approaches. The course will include an interactive lecture along with some hands-on demonstration of various methods for doing temperature mapping and BI placements in piping systems that are steamed in place.

Training will also include some exercises using risk assessment tools to determine if the system to be steamed should be considered “sterilized” or “sanitized,” as that decision has a significant impact on the validation approaches that would be utilized for the initial and periodic validations performed on the system. The primary objective of the course is gain a better understanding for how to design, operate and validate systems that are steamed in place.

Who Should Attend

This course is for personnel in Process Engineering, Validation and Quality.

Learning Objectives

Upon completion of this course, you will be able to:

• Identify the difference between a system that needs to be “sanitized” or a system that needs to be “sterilized”.
• Discuss system design concepts that will enhance the steam in place process.
• Describe conditions that can compromise the sterility of a sterilized system.
• Explain options for temperature mapping and BI placement (as applicable).
• List the potential Pro’s and Con’s for when to conduct the pre-use filter integrity test

Instructor

Kevin D. Trupp, Principal Consultant – Sterilization Technology and Compliance, Automated Systems Incorporated

Registration Fees

Biofilms

April 18, 2013 | 8:30 a.m. – 4:00 p.m.
PDA #476 | ACPE #0116-0000-12-476-L04-P | 0.6 CEUs
Type of Activity: Application

Course Description

This course will provide scientific understanding and real world practices for the management of bioburden and biofilm in pharmaceutical and biopharmaceutical production processes. Microbial control of pharmaceutical API and biopharmaceutical drug substance processes is a significant quality and compliance problem today. An extremely difficult to detect bioburden contamination has been recently reported in a major Biotech production facility, and a persistent biofilm problem at another facility recently led to medical supply shortages. Such events have revealed shortcomings in microbial control systems and resulted in increased regulatory concern. The course will review principles and best practices in the design of facilities/utilities/equipment to minimize bioburden with emphasis on the particular challenges of biofilm and will review the best currently available technology and sampling practices for bioburden and biofilm detection, including trend analysis and decision principles within the quality management system. Best practices in remediation of contaminated processes and equipment will be reviewed with case studies in remediation where possible.

Who Should Attend

This course is intended for scientists and technical staff, as well as middle to senior level managers, in pharmaceutical and biopharmaceutical Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing and Development.

Learning Objectives

Upon completion of this course, you will be able to:

• Discuss the principles and best practices of microbial control in pharmaceutical processes based on current best practices and regulatory expectations
• Explain the biology underlying bioburden development in pharmaceutical and biopharmaceutical drug substance production systems
• Explain the mechanisms surrounding biofilm formation and the complex interactions between that exist between planktonic and sessile modes of microbial contamination
• Provide information on typical control levels/limits for various types and stages of biopharmaceutical production systems, including critical utility systems
• Discuss principles and best practices in prevention, detection, and remediation of microbial contamination in pharmaceutical/biopharmaceutical drug substance or API production systems, including current regulatory guidance and expectations
• Manage microbial quality issues and conduct effective investigations, remediation, and regulatory interactions

Instructors

Marc Mittelman, PhD, Senior Managing Scientist, Exponent

Registration Fees

Single-Use Systems for Manufacturing of Parenteral Products

April 18, 2013, 8:30 a.m. – 4:00 p.m.
PDA #107 | ACPE #0116-0000-13-107-L04-P
Type of Activity:  Knowledge

Course Description

This course will provide students with critical concepts to consider when implementing a single use system (SUS) strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized small molecules and for bioprocesses that produce large-molecule biopharmaceutical products.

The course will discuss single use systems that are in either direct or indirect contact with the raw materials, intermediates, intermediate products, pharmaceutical drug substances or drug products.

Determining the optimal manufacturing strategy involves concepts from many disciplines. An effective evaluation will have a balanced viewpoint, with consideration from engineering, regulatory, quality project management and accounting. Balancing risks and rewards of a single use system (SUS) over a Multiple Use System (MUS) will help determine the most appropriate manufacturing strategy.

Learning Objectives

Upon completion of this course, you will be able to:

• Describe the necessary considerations and steps to accomplish a successful evaluation and implementation of a single use strategy
• Define process operating parameters and requirements necessary when examining single use solutions
• Determine potential impact of a SUS on product quality
• Compare and contrast single use technology and multi-use technology
• Assess risk by considering the potential for the single use system to interact with product or process fluids
• Outline supplier control strategies to ensure successful single use system implementation
• List minimum requirements, impact of different sterilization methods on materials of construction, and validity of testing approach

Instructor

Robert Repetto, Senior Director, External Affairs, Pfizer, Inc.

Registration Fees

Process Simulation Testing for Aseptically Filled Products

April 19, 2013 | 8:30 a.m. – 4:00 p.m.
PDA #374 | ACPE #0116-0000-12-374-L04-P | 0.6 CEUs
Type of Activity: Knowledge

Course Description

Process simulation testing is expected as part of a firm’s quality system to ensure the sterility of products manufactured using aseptic processing techniques. The verification of the ability of the process to produce sterile product is evaluated by the conduct of large scale automated process simulation testing (media fills). This course, which is based on a recently revised PDA Technical Report addressing the same subject, will address all the various elements required in the design and execution of a media fill, including personnel qualification, media selection and preparation, filling considerations, interventions, duration and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. Participants in this course will come away with an up to date understanding of current scientific and regulatory advances in the design, conduct and interpretation of process simulations. The knowledge they gain can be applied immediately to media fill operations in their own jobs. The use of risk-based decision making will be considered.

Who Should Attend

This course will be of value to managers and supervisors involved in the design, operation, evaluation and approval of process simulation testing. This includes persons working in operations, quality assurance, microbiology, and regulatory affairs. Individuals in facility engineering will also benefit from attendance.

Prerequisites

Individuals taking this course should have a basic understanding of aseptic manufacturing operations. This is not a course designed to teach the basic fundamentals of aseptic processing.

Learning Objectives

Upon the completion of this course, you will be able to:

• Identify the updated scientific and regulatory technology and expectations in the design, operation and interpretation of process simulations
• Discuss process simulation concepts and principles such as the number and frequency of simulations, worst case and risk assessment and ongoing evaluations
• Describe how to use risk management as it applies to aseptic processing simulations
• Discuss how process simulations can be applied to various types of aseptically processed products (lyophilized products and powders)
• Explain why environmental monitoring is an important element of process simulations
• Discuss the necessary documentation associated with process simulations
• Apply modern concepts to establish appropriate acceptance criteria for media fills, evaluate the results and as necessary investigate any failures and recommend appropriate corrective and preventive actions

Instructor

Harold Baseman, Principal, ValSource and Task Force Co-Leader of PDA
Technical Report 22 (Revised 2011); Process Simulation for Aseptically
Filled Products

Registration Fees

Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control

April 19, 2013 | 8:30 a.m. – 4:00 p.m.
PDA #442 | ACPE #0116-0000-12-442-L04-P | 0.6 CEUs
Type of Activity: Application

Course Description

Moist heat sterilization processes are considered to be “special processes” since the output of the process, product sterility, cannot be fully verified with test methodologies such as the sterility test. Therefore, it is absolutely essential that moist heat sterilization processes be properly designed, validated and controlled. This course will provide a foundational understanding of sterilization science (microbiology and thermal science) that will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control. The course is based on the latest revision of PDA’s most popular sterilization reference, PDA Technical Report No. 1, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control. Since its issuance, it has been widely utilized by industry and regulatory sterilization professionals in the development and assessment of sterilization programs across the globe.

Who Should Attend

Manufacturing Operations, Formulation, Engineering, QA/QC, Product and Process Development, Regulatory Affairs, Research and Development, Sterility Assurance, Technical Operations and Validation Professionals

Learning Objectives

Upon completion of this course, you will be able to:

• Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program
• Use a decision tree to select the most appropriate sterilization process based on the attributes of the load type
• Utilize the Semilog Survivor Curve Equation in support of the development and ongoing control of the sterilization program
• Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous/hard goods loads types
• List the critical elements of process performance qualification

Instructor

Mike Sadowski, Director, Sterile Manufacture Support, Baxter Healthcare

Registration Fees