Never Touch Sterile Surfaces with Bare Hands

Remember: Gloves must be worn and sanitized before touching any sterile surface—direct hand contact is a major GMP violation.

Why This Matters in GMP

Sterile surfaces are critical points of potential contamination in aseptic processing. Touching them with ungloved or improperly sanitized hands introduces microbial risk and compromises sterility assurance. Human skin carries a high microbial load and is a known contamination vector. Whether it’s a vial stopper, syringe plunger, or laminar airflow hood surface, GMP mandates barrier protection through gloving. This practice is fundamental to cleanroom behavior and hygiene protocol. Failing to wear gloves can lead to product contamination, batch rejections, or infections in patients—especially with injectable products.

Regulatory and Compliance Implications

FDA 21 CFR Part 211.113 requires control of microbiological contamination. EU GMP Annex 1 mandates sterile gloves for aseptic operations. WHO GMP and Schedule M emphasize use of protective apparel to prevent contamination of sterile zones. Regulatory inspections focus heavily on personnel practices and cleanroom discipline. Observations regarding improper glove usage or direct hand contact with sterile materials are classified as critical violations. Facilities must enforce strict gowning and aseptic behavior protocols with full documentation and training records.

Implementation Best Practices

• Ensure gloves are donned after gowning and sanitized before every sterile surface contact.
• Use sterile, powder-free gloves and replace them if damaged or contaminated.
• Train operators on aseptic techniques, including gloved hand positioning and disinfection.
• Audit cleanroom operations periodically for compliance with gloving SOPs.
• Include glove usage verification in media fill validations and operator qualification programs.

Regulatory References

• FDA 21 CFR Part 211.113 – Microbiological Contamination Control
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• WHO GMP – Personal Hygiene and Protective Apparel
• Schedule M – Sterile Area Garment and Glove Practices