The information in this course is paramount for continual successful of high quality pharmaceutical manufacturing. The day starts off by explaining the types of cleaning, passivation and their use in the pharmaceutical industry. Different types of aqueous cleaning, their advantages and disadvantages will be discussed along with different types of surfactants. Clean in Place or (CIP) and Clean-Out-of-Place (COP) passivation and rouging will be briefly covered. The second half of the course will go over cleaning validations in the pharmaceutical industry. Pharmaceutical cleaning validations are defined by FDA (Food and Drug Administration) as well as the ICH (International Conference on Harmonization), those details will be reviewed and discussed. The limit determination for each compound of interest will be discussed including how to do the calculations. Then we will talk about how clean is clean in the medical device industry and how to test for residuals. What type of testing/analysis will be reviewed? Finally, exercises and examples will be given throughout the day to give attendees the background and skill needed to succeed.

• Introduction
• Critical Cleaning
• Overview
• Aqueous Cleaning
• Ultrasonic
• Clean-Out-of-Place (COP)
• Surfactants
• Clean-In-Place Systems (CIP)
• Passivation and Rouging
• Cleaning Validation
• Pharmaceutical
• Solvents
• Materials of construction
• Technique
• Analysis
• Calculations
• Examples

A complete cleaning program may be difficult to construct, take a long time and be filled with pitfalls. The goal of cleaning validation is to ensure that a specific cleaning process will consistently clean to predetermined limits so as to prevent contaminants from leaving residues that will contaminate the next manufactured product. Cleaning validation is recorded proof that one can effectively and consistently clean a system or piece of equipment.

As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. FDA's risk-based regulatory programs focus on cross-contamination. The understanding of the management of cradle-to-grave product control is the basis for an effective cleaning validation program.

The presentation will include 483's that have been given out by the FDA concerning cleaning validations. This information is important to learn from other companies' mistakes, oversight and nearsightedness.

Also presented will be how to determine the residual limits using residue limits that meet all necessary regulatory requirements :

Besides direct sampling of equipment, the use of coupons is a valuable and cost effective means of assuring that proper cleaning procedure is being employed.

The goal of this program is to present specific information on how to establish a compliant cleaning validation program, and to provide a useful overview of the principles and technology of residue removal, sampling technique, solvent usage and residue measurement on product production or holding contact surfaces.

• Cleaning validation strategies including incorporation into a Validation Master Plan
• Preparing Cleaning Validation SOPs
• Setting Residue Limits and Acceptance Criteria
• Determination of proper swab technique on coupons
• Execution and data interpretation
• Book on Aqueous Cleaning will be given to all participants