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Pharmaceutical Validation
validation refers to establishing documented evidence that a process or system, when operated within established parameter
perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality
attributes

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VALIDATION OF VAPOR PHASE HYDROGEN PEROXIDE STERILIZATION Pharmaceutical Master Validation Plan
PROCESS Pharmaceutical Equipment Validation
Principles of Process Validation
Vapor phase hydrogen peroxide (VPHP) is a relatively new sterilization gaseous
Pharmaceutical Computer Systems Valid
agent that is rapidly becoming the gaseous sterilant of choice for many applications,
the most well known being the sterilization of barrier isolation systems. Cleaning Validation Manual
Its advantages over other gases, such as ethylene oxide, peracetic acid, chlorine Validation of Aseptic Pharmaceutical Pro
dioxide, and glutaraldehyde, include the following: HPLC Method Development and Validati
1. It does not require temperatures above ambient. Pharmaceutical Analysis
2. There is little or no concern about residual by-products. Validation Standard Operating Procedure
Vapor phase hydrogen peroxide equipment and process are described elsewhere Validation and Qualification in Analytical
[36]. The basic steps in the process are dehumidification, conditioning, Laboratories
sterilization, and aeration. More specifically, there are five steps that must be part Pharmaceutical and Medical Device Vali
of the validation protocol [36]. Validation of Aseptic Pharmaceutical Pro
1. Cycle development
Pharmaceutical Water: System Design, O
2. Temperature distribution and Validation
3. Vapor distribution
Product Details Cleaning Method Validat
4. Biological challenge Solid Dosage form
5. Aeration verification
FDA Process Validation Guidance
Cycle development parameters include temperature, airflow rate, humidity, liquid
21 CFR Part 11
peroxide concentration, liquid peroxide delivery rate, peroxide vapor delivery
temperature, and peroxide vapor half-life. Temperature distribution qualification Facility Validation
involves the use of temperature sensors located throughout the sterilant
delivery line and throughout the enclosure. Vapor distribution qualification uses chemical indicators to measure VPHP exposure levels.
Biological challenges Pharmaceutical validation
involve placement of biological indicators, normally Bacillus stearothermophilus
spore strips or stainless steel coupons at many different locations inside the Current Good Manufacturing Practice
enclosure, particularly in those areas most difficult for vapor to contact and Handbook: 21st century pharmaceuti
sterilize. Aeration verification determines the parameters (e.g., time, air exchange regulatory expectations -
rates) necessary to reduce VPHP levels within the system to a certain
Validation of Pharmaceutical Process
value, usually ≤5 ppm. Vapor phase hydrogen peroxide sterilization cycles are
ultimately validated in the same way as traditional aseptic validation processes Pharmaceutical Water: System Desig
via the use of sterile media fills. Operation, And Validation, 2Nd Editio
(Original Price £ 107.00) -

Solid Oral Dose Process Validation: T

Labels: VALIDATION OF VAPOR PHASE HYDROGEN PEROXIDE STERILIZATION PROCESS Basics, Volume 1 (AAPS Introduction
Pharmaceutical Sciences) -

Analytical Method Development and

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3 comments: Types of process validation

1. Types of process validation .Dep
Unknown said... on when it is performed in relation to
production, validation can be prospec
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November 29, 2010 at 2:39 AM JM Tech. Do-Young Ahn 0/0/00 Moist
Sterilization 2 Definition Sterilizatio
act or process, physica...
Bibhuti said...
 Pharmaceutical Validation. Free download SOP for Validation. Interactive protocol templates. SOP - CALIBRATION OF BALANCES
1.0 PURPOSE: To provide a written
more information procedure for the steps to be followed
calibration of balances. 2.0 SCOPE: A
October 30, 2012 at 8:24 PM
Concept of Process Validation For
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