Ycoplasma Contamination Control and Prevention
Q

How to Prevent Mycoplasma Contamination in Pharmaceutical Manufacturing

A

A. Raw material and cell bank testing: Ensure all materials and cell stocks are mycoplasma-free before use.
B. Personnel entry and operations: Enforce strict access control and comprehensive aseptic operation training.
C. Equipment sterilization and routine sanitation: Validate cleaning protocols and schedule full-environment sanitization regularly.
D. Physical and procedural separation: Implement physical barriers and process separation to minimize contamination risk.
E. Contamination response SOPs: Develop and enforce emergency SOPs to contain and eliminate contamination swiftly before it spreads.

Q

How to Eliminate Mycoplasma

A

A. Sterilization of instruments and equipment using autoclaving (steam sterilization) or peracetic acid-based agents.
B. Environmental decontamination: Use hydrogen peroxide (H₂O₂) vapor for space decontamination; after exposure, leave the area unoccupied and then perform follow-up mycoplasma testing to confirm decontamination.
C. Limitations of alcohol and UV light: These are only partially effective; also, don’t overlook the importance of eliminating mycoplasma spores if present.

Q

Global Antibiotic Resistance Trends in Mycoplasma

A

Between 1996–2005, around 20% of wild mycoplasma strains showed resistance to macrolides and lincosamides, with isolates found in hosts ranging from wild boars to plants. Resistance rates have increased roughly fourfold in the last 10–20 years.
In Europe and the U.S. from 2019–2024, increasing reports have documented multidrug-resistant strains, including resistance to erythromycin, fluoroquinolones, and notably high resistance to both macrolides and lincosamides.
These resistance issues must be considered in pharmaceutical manufacturing processes and detection protocols.

Q

How to Prevent Mycoplasma Contamination in Cell Culture

A

A. Rational laboratory design: Separate air exhaust systems and access pathways from bacterial testing areas.
B. Routine disinfection: Especially after contamination is detected, including mycoplasma, leave the laboratory idle for at least 1–2 months for thorough decontamination and validation.
C. Personnel and materials control: Monitor all incoming personnel and materials for possible contamination; include staff health checks and acceptance testing of incoming supplies.
D. Aseptic technique awareness: Enforce strict aseptic handling during all laboratory operations.

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