IAL is a cGMP compliant facility available for developing, validating and performing analytical procedures used in equipment cleaning validation. Cleaning validation is a multi-step process that begins with focusing on the objective of the validation process. Typically, the objective is to prevent the adulteration or contamination of drug products that are manufactured on non-dedicated equipment. Cleaning studies demonstrate that chemical and microbiological residues that are detected are acceptable to predetermined criteria.
Prior to developing the methods and conducting the validation, some important questions need to be asked. Questions such as do we utilize one cleaning process for all products or use different cleaning processes for different products. Perhaps a cleaning process for water soluble residues and another for non-water soluble residues will be utilized. IAL will work with you to determine the most efficient method(s) to clean your equipment so that you will meet all FDA requirements.
Upon request, IAL will work closely with our clients to:
- Determine the processes for cleaning equipment. The most commonly used sampling techniques are swabs and rinsate samples. Other techniques are available should the situation warrant it. In addition to determining the cleaning technique, a residue maximum concentration limit or residue acceptance limit should be established. The residue acceptance limit should be verifiable and analytically achievable.
- Develop analytical methods to analyze the chemical and or microbiological residues on manufacturing equipment. A method feasibility is typically done at this point to determine whether the established maximum concentration limit or residue acceptance limit can be achieved and thus the method is suitable for it's purpose. Specificity and sensitivity will be documented.
- Determine how cleaning processes will be validated. Critical aspects of the validation are typically limit of detection (LOD), limit of quantitation (LOQ), selectivity, linearity, precision and accuracy.
- Write validation protocols that address who is responsible for performing and approving the validation, sampling procedures, analytical procedures and acceptance criteria for chemical and microbiological residues.
- Execute the validation protocol(s).
- Write the final validation report(s) which includes all the data and is approved by management. All data should support the conclusion that the cleaning process meets the acceptance criteria set forth in the validation protocols.
- Help establish the required frequency of equipment cleaning. Ongoing monitoring confirms that equipment surfaces are free of chemical and microbiological contaminants.
IAL's consultative approach has worked successfully on our past projects. Our scientists have developed and validated methods to quantitatively detect residues of various substances and contaminants from equipment surfaces. Templates for test methods and protocols are available so that customized protocols can be quickly developed for cleaning validation of non-dedicated manufacturing equipment.
Contact us to obtain excellence in service and quality data, and to allow us to become a valuable and trusted member of your team.