Type C cleaning in the pharmaceutical industry refers to shift-end cleaning. This is a general cleaning procedure performed at the end of a work shift, preparing the equipment and manufacturing area for the next day's operations. It's distinct from other cleaning types, such as Type A (product-to-product changeover) and Type B (batch-to-batch changeover), which focus on cleaning between different production runs.
Understanding Type C Cleaning
- Purpose: To maintain a clean and sanitary environment, preventing cross-contamination and ensuring the quality of products manufactured on subsequent shifts.
- Scope: This cleaning encompasses the general cleaning of equipment, work surfaces, and the surrounding area. The specific procedures will depend on the equipment and manufacturing process.
- Frequency: Performed at the end of each shift.
- Documentation: All Type C cleaning activities should be properly documented, following standard operating procedures (SOPs). This documentation is crucial for quality assurance and regulatory compliance.
Several sources confirm this definition:
- PharmaGuideline.com states that Type C cleaning is "Shift end cleaning." https://www.pharmaguideline.com/2011/05/sop-for-procedure-for-changeovers.html
- Pharmainform.com describes Type C cleaning as "general cleaning that is performed at the end of the shift and where the work is to be started again on the next day." https://www.pharmainform.com/2020/12/line-clearance-in-pharmaceutical-industries.html
- An FDA 483 observation mentions "Type C Cleaning" in the context of shift-end cleaning procedures. https://www.fda.gov/files/drugs/published/Aurobindo-Pharma-Ltd-India-05242019-483.pdf
Example: A pharmaceutical manufacturing line producing tablets would undergo Type C cleaning at the end of a shift, involving cleaning the tablet press, conveyor belts, and surrounding areas to prepare for the next day's production.
