Lessons Learned in the Design, Installation, Start-Up and Qualification of Clean Compressed Air Systems for cGMP Manufacturing

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Category clean room environmental monitoring program, corrective and preventive action fda, environmental control in pharmaceutical industry, fda audit training

Deadline: April 26, 2017 | Date: April 26, 2017

Venue/Country: New Hyde Park, U.S.A

Updated: 2017-03-20 19:17:24 (GMT+9)

Call For Papers - CFP

In the pharmaceutical industry, compressed air is used for a number of production and packaging applications, including blowing off and drying bottles prior to filling, conveying pills, providing air for pneumatically controlled valves and cylinders, as well as breathing air systems.

Each of these applications requires a different level of air quality and a different combination of air treatment to meet the needed quality. Because the uses of compressed air within the industry vary so greatly, there is no set standard in place that every process must adhere to.

While the FDA may not have issued a directive for compressed air quality in the pharmaceutical industry, there is still a resource available to help select appropriate air treatment components for a compressed air system.

A typical pharmaceutical plant might have a compressed air specification of ISO Quality Class 1.2.1—Class 1 for Solids and Dust, Class 2 for Humidity and Liquid Water, and Class 1 for Oil.

ISO 8573.1:2010 was developed by ISO — the International Organization for Standardization — as a reference for specifying compressed air quality. This standard is not industry or application specific and includes three categories: solid particles/dust, humidity and liquid water, and oil. Within these categories are classes, ranging from 0 to X. While there may not be a pharmaceutical industry standard, the equipment used in these processes may have a certain ISO air quality specified, making it relatively easy to select compressed air dryers and filters to meet the specification.

So why do facilities have so many problems? This Webinar will look at the industry standard best practices and share lessons learned from half-a-dozen installations for top-tier Pharmaceutical Manufacturing Companies, and dispel some “myths” about compressed air.

Why Should You Attend:

Every pharmaceutical manufacturing facility utilizes Compressed Air, and it is often in direct contact with product. Failures in the design, installation, start-up and qualification of these systems could lead to costly delays in production and quality failures leading to regulatory sanctions. Every plant engineer, operations engineer, manufacturing and quality resource needs to know what the risks are when defining and monitoring the system user requirements and quality specifications. A common topic that is often misunderstood and that misunderstanding costs real time and real money. The lessons learned in this webinar are intended to help industry recognize, address and mitigate those real risks.

Areas Covered in this Webinar:

Compressed Air - Importance of Quality

Pharmaceutical Compressed Air System Design

Contamination Types and Sources

Contamination Prevention

International GMP Testing Standards

Testing Methods and Specifications

Failure Mode Effects Analysis of REAL WORLD examples

Learning Objectives:

Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system.

A detailed description of a typical pharmaceutical compressed air system with its individual components will be provided. Engineering schematics will also be included. All component functions will be detailed with recommendations as to which component type is considered optimal.

The four contamination sources in compressed air will be discussed. They are:

Solid particulate

Water content

Total oil content

Microbial bio burden

Suggestions will also be provided for preventing contamination, starting at design. Sampling and testing methodology for each of these specifications will be discussed as well.

Finally, REAL WORLD lessons learned from a half dozen installation will be presented. For each of these, the presentation will discuss cause and effect

Who Will Benefit:

Quality Assurance

Environmental monitoring

Microbiology

Manufacturing

Validation

Engineering

Maintenance

Operations

All Pharmaceutical, All Biotech, All Medical Device, Food and Beverage

Speaker Profile:

Mr. Gibbs is a highly motivated leader with a proven project management track record. Able to interface with and motivate people at all levels of an organization or project and across all business units, he works diligently on the application of best practices. He possesses an extensive experience organizing and supervising the business activities of project teams, within budget and to tight timetables. An innovative thought leader who is well respected by industry peers for creative and applicable solutions to complex problems, he has proven planning and brainstorming expertise that has established a framework for successful projects and business practices.

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