Cleaning Validation Services
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 services 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 when it comes to Equipment Cleaning Validation.
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
Equipment Cleaning Validation Expertise
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.
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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.
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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.
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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.
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Resources
Cleaning Validation Points to Consider
Clean Hold Time
Dirty Hold Time
Pharmacological / Toxicological Terms
Allowable Daily Exposure Limit (ADE), Permitted Daily Exposure Limit (PDE), Occupational Hazard Category (OHC).
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.
Life Cycle Approach
A three stage approach to cleaning validation that begins in the process design phase below.
Our Life-Cycle Approach to Cleaning Validation
Example Projects
FAQ
Cleaning validation ensures that equipment is consistently cleaned to remove residues from previous batches. It provides documented assurance that contamination risks are minimized and product quality is maintained.
Cleaning Validation Services cover cleaning process design, validation protocol development, sampling strategies, residue analysis, and documentation. These services help ensure compliance and consistent cleaning effectiveness.
Equipment Cleaning Validation verifies that cleaning procedures effectively remove residues between production cycles, reducing the risk of cross-contamination—especially in multi-product manufacturing environments.
A cleaning validation program should be implemented during new equipment setup, process changes, or new product introductions to ensure cleaning procedures meet regulatory and operational requirements.
Acceptable residue limits are determined based on factors such as product potency, toxicity, solubility, and regulatory guidelines, ensuring safe and compliant manufacturing processes.
