Cleaning Validation
Cleaning validation provides a high degree of assurance that a specific cleaning process consistently cleans residual to pre-defined limits of acceptability (product or cleaning chemistry related). A cleaning validation program will provide documented evidence that residuals from previous processing and cleaning do not adulterate and adversely affect the safety and quality of the next product manufactured.
Capabilities
Cleaning Process Design, Sample Site Evaluation/Rationale, Program development, validation, and verification for Solid Dose, Ointment, Creams, Liquids (OCL’s), Parenterals, CIP, and Filling lines.
Experienced
Mangan Biopharm has extensive experience in developing and executing cleaning validation programs in multi-product facilities. We understand the challenges of ensuring a consistent and effective cleaning program in high throughput facilities.
Professional
Our highly skilled team can help your organization ensure that equipment cleaning procedures are removing residues to pre-defined levels of acceptability. We can deliver a complete package from development and execution of engineering studies and protocols, to creation of cleaning matrices, swab rationales, cleaning procedures, equipment cleaning and use logs, and training documentation.
What we Do
Cleaning Validation Expertise
Establishing Acceptance Criteria
Mangan can help you leverage your specific manufacturing process knowledge to develop risk based cleaning process acceptance criteria that accounts for soil/residue, process sampling technique, and your analytical methods used for detection.
Cleaning Process Design
Mangan can provide guidance and execution of various cleaning process design studies, including relative cleanability, degradation, surface swab recovery, rinse recovery, visual residue limit, and cleaning sample stability.
Project Execution
Sometimes new products or new processes create a gap in your resources and you need a trusted partner who can provide professional services to help fill that short term need. Mangan Biopharm offers professional staff that have been instrumental in new product introductions and cleaning validation at some of the largest biopharmaceutical companies in the world.
Change Control & Assessments
A critical component of a quality system is a robust change control process that incorporates a thorough risk assessment. Mangan can help you perform process and product impact assessments to ensure the integrity of your product lifecycle is maintained.
Resources
Cleaning Validation Points to Consider
Clean Hold Time: The period of time that the cleaned equipment may be held prior to production use before it is required to be re-cleaned.
Dirty Hold Time: The maximum amount of time that may elapse between the completion of processing on the equipment and the commencement of the cleaning procedure.
Pharmacological / Toxicological Terms: Allowable Daily Exposure Limit (ADE), Permitted Daily Exposure Limit (PDE), Occupational Hazard Category (OHC).
Life Cycle Approach: A three stage approach to cleaning validation that begins in the process design phase (Stage 1), proceeds to the process qualification phase (Stage 2) and continues throughout the life of the process, Continued Process Verification (Stage 3).
Stage 1 Key Activities: Equipment Cleaning Sample Site Assessment, Grouping of Soil/Residue, Cleanability Studies, Cleaning Process Evaluation, Degradation/ Fragmentation Study, Analytical Method Verification, Establish Acceptance Criteria
Stage 2 / Stage 3 Key Activities: Process Qualification based on pre-determined number of replicates (Stage 2), Continued Process Verification (Stage 3) Approach and Execution
Maximum Allowable Carryover (MACO): A calculation which determines the allowable amount of product carryover “residual” on non-dedicated manufacturing equipment which will then be incorporated into the next product.
Indicator/Worst Case Species: A target molecule that is considered the worst case for solubility, toxicity, potency, and cleanability. In some cases, it may be appropriate to select multiple worst case molecules.
“Mangan delivers on their projects with talented resources and the technical know how to offer solutions to problems instead of waiting on us to solve them. I appreciate their dedication and willingness to do what it takes.”
“We had some unexpected challenges that consumed our internal resources at the same time a critical project was in progress. Mangan stepped in and provided several validation engineers to fill the gap. Great job guys!”
“A trusted partner is often difficult to find. With Mangan, we have been pleased with their responsiveness and overall quality of their staff. What started as one small project has grown into a trusted partnership.. “