Nonaseptic processing

Terminology of Nonaseptic Process Validation Kenneth G. Chapman... 

Validation of a sterilization process differs from validation of a nonaseptic process in several significant ways. A sterilization process is a treatment process from which the probability of any micro-organism survival is less that 10 6, or one in a million. Sterility means the absence of all life. Aseptic means the absence of pathogenic organisms. The difference between nonaseptic and aseptic process validation is that the aseptic process includes at least one measure that is intended to remove pathogens. 

The validation era brought with it the need for humans involved to communicate with new terminology. The purpose of this chapter has been to identify and explain the key terminology needed to understand nonaseptic process validation. A currently popular, lucid, and accurate definition of process validation itself is well-organised, well-documented common sense. 

Validation of aseptic pharmaceutical processes is specihcally assembled in the second edition as a reference for use by managers, supervisors, and scientists in the pharmaceutical industry. The primary intent of this work is to guide design engineers, manufacturing personnel, research and development scientists, and quality control professionals in validating those processes needed for nonaseptic and aseptic pharmaceutical production. 

Syed Imtiaz Haider has a Ph.D. in chemistry and is a quality assurance specialist with over 10 years of experience in aseptic and nonaseptic pharmaceutical processes and equipment validation, in-process control, and auditing. Dr. Haider is the author and co-author of more than 20 research publications in international journals dealing with products of pharmaceutical interest, their isolation, and structure development. He is a professional technical writer and author of more than 500 standard operating procedures based on FDA regulations, ISO 9000, and ISO 14000 standard. 

Validation of a nonaseptic system is also occasionally referred to as process validation or solid dosage validation. While both terms are descriptive,... 

Institute of Validation Technology Standards Committee. Proposed validation standard VS-1-nonaseptic pharmaceutical processes. J Val Tech 6(2) (Feb. 2000). 

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