ASME BPE Guidelines for Pharmaceutical Equipment

ASME BPE Guidelines for Pharmaceutical Equipment

ASME BPE - (The American Society of Mechanical Engineers - Bio processing Equipment)

 

Various regulatory authorities across the globe are taking remarkable efforts to update GMP regulations and standards to improve medicines quality. However these agencies are very non specific about the design/engineering requirements of  pharmaceutical process equipment/ system, and here comes the importance of organizations like ISPE (International Society for Pharmaceutical Engineering), ASME (American Society of Mechanical Engineers), ASTM (American Society for Testing and Materials) to setting up the standards which  provides the requirements applicable to the design of process equipment/system  used in the bio processing, pharmaceutical and personal-care products industries.

 

Till 1997 there were no industry standards directed at the needs and requirements of the pharmaceutical industry. Prior to that time it was a patchwork effort at resourcing and adopting non pharmaceutical-related codes and standards and then modifying them in order to meet the more stringent requirements of the Food and Drug Administration (FDA).

The American Society of Mechanical Engineers first published a standard in 1997 for Bio processing Equipment and it has since become a global standard for designing  and building equipment and systems used in the bio processing, pharmaceutical and personal-care products industries. This standard incorporates current best-practices for enhancing product purity and safety. ASME standard covers materials, design, fabrication, inspections, testing and certification of process equipment and system.

 

ASME BPE standards are developed and maintained by a balanced group of experts and is continuously updated to support industry accepted practices. Updation includes multiple stages of approval before publication. Corrections and clarification of published guidelines can be requested by any one.

 

This post is an introductory note and will discuss in detail about the ASME BPE standards in upcoming posts......

Much awaited post for ‘Design Requirements of Pharmaceutical Process Piping’ will be published soon.....

 

V- Model Validation Concept in Pharmaceuticals

V- model means Verification and Validation model. It is a widely accepted reference model for computer system validation and was introduced by International Society of Pharmaceutical Engineers (ISPE) in 1994 in the first edition of their Good Automated Manufacturing Practices guideline, (gAMP).

It is called the V-model because of it’s characteristic “V” shape. The left arm of the “V” represents the planning / specification phases such as User Requirements Specification, Functional Specification, Detailed Design, and the right arm of the “V” represents the execution-validation phases such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) and both the arms converge at the Build and Unit Testing phases at the V-Point.

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The V-model provides a logical sequence that helps to organize the complex activities of defining a project scope, executing it, and qualifying it.

The V model provides an excellent basis for design control and tracking design changes through the proceeding of the project.

CODEX ALIMETARIUS - International “Food Law” or “Food Code”

CODEX  ALIMETARIUS  International “Food Law” or “Food Code”

The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety. The Codex international food standards ensures product safety internationally and  facilitate global trade.

 

Codex commission is responsible for publishing Codex Alimentarius. The Codex Commission was established in 1963.It is Subsidiary of Food and Agriculture Organization (FAO), United Nations (UN)and World Health Organization (WHO).

Isolators in Pharmaceutical Industry

Isolators in Pharmaceutical Industry

In Pharmaceutical industry isolation technology is either used to protect the product from the operator (ex: aseptic processes), or protect the operator from the product (ex: potent product handling).

Isolator is a leak tight enclosure which acts as a physical barrier and provides a workspace, which is separated from the surrounding environment. 

It usually consists of a shell, viewing window, glove/sleeve assemblies, supply and exhaust filters, light (s), gauge (s), Input and Output openings (equipment door airlocks, Rapid Transfer Ports (RTPs), etc.), and various other penetrations. There are two types of isolators:

1. Closed Isolators – Isolators operated as closed systems do not exchange unfiltered air or contaminants with adjacent environments. Their ability to operate without personnel access to the critical zone makes isolators capable of levels of separation between the internal and external environment unattainable with other technologies. Because the effectiveness of this separation, closed isolators are ideally suited for application in the preparation of sterile and/or toxic material. Aseptic and Containment isolators are two types of closed isolators.

2. Open Isolators – Open isolators differ from closed isolators in that they are designed to allow for the continuous or semi-continuous egress of materials during operation, while maintaining a level of protection over the internal environment. Open isolators are decontaminated while closed, and then opened during manufacturing. Open isolators typically are used for the aseptic filling of finished pharmaceuticals. 

The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides an absolute separation between the operator and product. The operator can perform tasks through half-suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control and oxygen control.