In recent years mold contaminations and recalls have been a focus for the FDA. This wave of mold related inspections is in response to a deadly fungal meningitis outbreak linked to contaminated steroids from a now infamous compounding pharmacy. A risk-based approach to mold is required in order to prevent a catastrophic outcome.
A specific mold may be detrimental in one product but may have no clinical implication in another. Understanding mold, its proliferation methods and its clinical relevance is the solution. The key is not to panic at the first sight of mold.
When facility design and maintenance, risk based environmental monitoring and disinfection programs as well as airflow patterns are not adequate it is hard to track, prevent or control mold.
While non-sterile production facilities do not require stringent environmental controls, many mold species are very critical in certain non-sterile products.
Understanding Mold (Hands-On Exercise)
Understand mold classes, sporulation patterns and how easy to kill mold can switch its proliferation method where the spores are impossible to eradicate.
- This will be a hands on exercise using fungal reference texts and images
- This exercise will allow attendees to understand that no matter what method you use, you may not always have the correct identification.
- Learn about the sources of various cleanroom mold isolates and develop a prevention plan
- Understand where and how these mold can proliferate in your facility
- Case studies where extensive investigations and CAPAs have led to little or no remediation
- Discussion on FDA 483s related to mold contaminations
- Mold Myths and Facts (Classroom Discussion)
- Myths about disinfection and disinfectant qualification related to mold removal
- Understanding the fungicidal activity of various disinfectants used in the industry
- How fungicidal label claims are established and why they could be misleading
- Dispelling myths about resistance of mold to disinfectants-some mold is hard to kill
- Common errors in disinfectant efficacy testing that gives false confidence in mold kill
- Cleaning practices that actually encourage mold growth
- Contact time myth – understand that disinfectant activity does not stop at 10 minutes
- Antimicrobial/Preservative efficacy testing deficiencies-Understand the type of mold tested for efficacy vs other
- mold types found in cleanrooms
Investigating Mold Contaminations (Classroom Discussion)
Often the risk of mold contamination is not addressed until contamination has happened!
Understand how mold gets into your facility and how it can grow in the facility and in process materials. This can assist a company to comprehend possible mold contamination of the product.
Occasionally mold contamination leads to major facility and process design changes after it has made its presence known in the cleanroom in large quantities or has ended up in the product.
- Understand why investigating and managing mold contamination can be difficult without proper knowledge of mold and controlled environments
- Points to consider when investigating mold contamination
- Raw materials
- Laboratory environment and equipment-a common cause of mold related failures
- Growth media quality and storage-a common cause of false positive mold results
- Cleaning supplies and cleaning procedures
- Why excessive cleaning and disinfection or fogging is not the solution when it comes to cleanroom
- contamination by mold
- Clinical Relevance of Objectionable Mold (Classroom Discussion)
- Learn about what mold is objectionable via which mode of administration
- Mold Infections of the central nervous system
- Systemic mold infections
- Mold infections via nasal and inhalation pathway
- Cutaneous and sub-cutaneous mold infections
- Vaginal and rectal mold infections
- Oral mold infections
- Nosocomial mold infections
- Growth of mold infections over years
- Guidelines on how to assess risk of mold in your product
- Understanding the level of risk and making changes to remediate the situation
North Carolina Biotechnology Center
Hamner Conference Center- Congressional Room
15 TW Alexander Dr, Durham, NC 27710