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Cleaning Validation

Visible Residue Limit Determination and Ruggedness 

 
 March 14, 2017 WEBINAR
NOON - 1:30 pm Eastern Standard Time 
.

This Web Seminar will present a comprehensive overview of the use of Visible Residue Limits (VRLs) for cleaning validation for product contact surfaces of equipment in the pharmaceutical industry.  VRLs are the level below which no residue is visible under defined parameters and are applicable for cleaning validation when they are lower than the calculated cleaning acceptance limit.

VRLs can be established for APIs, products, excipients, and detergents as needed.  Decreasing amounts of material are spiked onto coupons and dried.  The dried coupons are viewed under defined viewing conditions by a number of observers, who determine the lowest level of material they can see.  The VRL is the lowest level of material that all observers can see under the defined viewing conditions.

The ruggedness of VRL determination depends on a number of factors.  In part one of the presentation, the basic conditions that impact the ability to see residual material is examined.  The primary parameters are the defined viewing conditions: distance, angle and light level.  The most critical of the three is the viewing angle.  Other ruggedness parameters addressed include: the spotting solvent, observer technique, observer subjectivity, observer experience, and residue composition.

Part two of the presentation will examine the effects of coupon presentation on the ruggedness of VRL determination.  The differences between a sequential presentation array and a random presentation array of the coupons for VRL determination are evaluated.  The practical implications of the presentation array chosen for VRL determination are also considered.

Part three of the presentation will look at VRL determination on different materials of construction (MOCs).  A range of products on a range of MOCs are examined.  Intuitively, the VRL for a single material will differ for different MOCs.  The practical implications of VRLs on different MOCs are considered and mitigation practices are proposed.    

Teaching objectives for this presentation include:

·       VRL determination under defined viewing conditions

·       Relationship of VRL to cleaning acceptance criteria

·       Criticality of viewing conditions for VRL ruggedness

·       Preparation parameters of VRL samples

·       Observer effects on VRL determination

·       Coupon presentation effects on VRL ruggedness

·       VRLs on different materials of construction

·       Mitigation practices to enhance VRL applications

 
FEE: 
$385 for one (1) person.
$700 for 2-5 people
$999 for 6-10 people
Instructor: Richard Forsyth

Richard Forsyth is a Principal Consultant with Forsyth Pharmaceutical Consulting.  He is responsible for customer support for Cleaning Validation and Cleaning related topics.  He has worked as a consultant for four years and prior to that worked in as an Associate Director with Merck & Co. for 31 years.  He has been involved with Cleaning Validation for over 20 years.  Mr. Forsyth has a broad range of analytical experience including methods development and validation as well as formulation development and project management.  Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, Pennsylvania, USA.

 
 
 
ECCWEB660