1 / 7

Measuring Bioburden for Cleaning Validation Protocols

It becomes necessary to measure bioburden during the cleaning validation process in Pharmaceuticals.

NareshB
Download Presentation

Measuring Bioburden for Cleaning Validation Protocols

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Measuring Bioburden for Cleaning Validation Protocols Why Address? Pharmaguddu.com

  2. For process equipment Initial regulatory focus: drug active and cleaning agent FDA guidance not apply to micro residues But do address micro concerns on storage Practical matter Microbial residues are related to cleaning process Microbial residues are potential contaminants of next produc Issues?

  3. Probably not a problem except… Little or no documentation Approaches to control Setting limits Analysis & sampling Documentation strategies New validation Already validated process CEHT (expiry) Control Measures?

  4. Bioburden of raw materials “Cleaning” itself Sanitizing agents Drying of equipment Good Cleaning Factors hostile to microbes -- High temperature pH extreme Oxidizer (biocidal) Surfactant (wetting, physical removal) Removal of chemical residues -- Microbe “trap” Nutrient In most cases, effective cleaning can meet microbial control objectives

  5. Separate Sanitizing Steps Separate sanitizing step Possible agents Hypochlorite Quats Alcohol Hydrogen peroxide Peracetic acid May require final rinse (exc. alcohol & peroxide) Another residue concern

  6. Final rinse Rinse to remove sanitizing agent residues Unless rinse with sterile water, will reintroduce organisms into system Sanitizing option Sanitize after storage (as opposed to after cleaning) Address rinsing Address worst case & demonstrate effective sanitation under those conditions Storage time & conditions Worst case “starting conditions”

  7. Is sanitizing necessary? Major issue: microbes in equipment at beginning of subsequent manufacturing process How demonstrate – data is critical Scale-up studies (after clean/after sanitize comparison) Monitoring data on just cleanin

More Related