Replica Dental Lab

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Infection Control Policy

Infection control is a critical component of Replica Dental Lab’s operations. This policy outlines our standards and protocols to ensure a safe, hygienic environment for fabrication, handling, and processing of all dental restorations. We adhere to Indian Standards (IS 6403), ADA standards, and ISO guidelines for infection prevention.

1. Laboratory Standards and Compliance

Replica Dental Lab operates in strict compliance with:

  • Indian Standards (IS) for dental materials and laboratory procedures
  • ISO 13485 (Medical Device Quality Management System)
  • ADA (American Dental Association) professional standards
  • OSHA guidelines for laboratory safety and bloodborne pathogens
  • Local municipal and environmental regulations for waste disposal

2. Impression and Case Handling Protocol

1 Impression Disinfection

All physical impressions and models received are treated as potentially contaminated and undergo immediate disinfection:

  1. Initial Assessment: Impressions are inspected for blood, saliva, or visible contamination upon receipt
  2. Rinse: Impression is rinsed under running water to remove gross contamination
  3. Disinfection: Impression is sprayed with hospital-grade disinfectant (0.5% sodium hypochlorite or equivalent)
  4. Contact Time: Disinfectant allowed to work for minimum 10 minutes
  5. Final Rinse: Impression is rinsed thoroughly to remove disinfectant residue

2 Disinfectants Used

We use EPA-approved, ADA-accepted disinfectants with broad spectrum activity:

  • Sodium hypochlorite (0.5%) – effective against bacteria, viruses, fungi, spores
  • Glutaraldehyde-based disinfectants – for chemically sensitive materials
  • Quaternary ammonium compounds – for materials sensitive to chlorine

3. Laboratory Environment and Facility Standards

1 Workspace Hygiene

  • All work surfaces are cleaned and disinfected daily
  • CAD/CAM milling units are wiped down between cases
  • 3D printing equipment is maintained per manufacturer specifications
  • Laboratory tables and equipment are disinfected using hospital-grade surface cleaners
  • Separate contaminated and clean zones are maintained

2 Air Quality and Ventilation

  • Laboratory is equipped with adequate ventilation systems
  • HVAC systems are maintained and filters are changed regularly
  • Negative pressure zones prevent contamination spread to other areas

4. Personal Protective Equipment (PPE)

All laboratory staff are required to wear appropriate PPE:

  • Gloves: Changed between cases and when visibly contaminated
  • Lab Coat: Worn at all times, changed if contaminated
  • Eye Protection: Safety glasses worn during milling and finishing procedures
  • Face Mask: Worn during high-dust-generating procedures
  • Footwear: Closed-toe, non-slip shoes required

5. Hand Hygiene Protocol

Staff are trained in proper hand hygiene:

  • Hands are washed with antimicrobial soap before and after handling contaminated impressions
  • Hand sanitizer is available at all workstations
  • Proper handwashing technique (40-60 seconds) is enforced
  • Jewelry, watches, and artificial nails are prohibited during case handling

6. Sterilization and Disinfection Procedures

1 Materials and Tools

All reusable tools and equipment are sterilized:

  • Articulators, shade guides, and measuring tools are disinfected between cases
  • Burs, drills, and milling tools are replaced or sterilized after each use
  • Heat-sensitive items are chemically sterilized using high-level disinfectants
  • All tools are stored in sterile, dedicated containers

2 Autoclaving Standards

For autoclaved items (where applicable):

  • Steam sterilization at 121°C for 15-30 minutes at 15 PSI
  • Biological indicator tests performed quarterly
  • Maintenance and calibration records are maintained

7. Material Handling and Storage

1 Raw Material Quality

  • All materials are sourced from certified suppliers with quality certifications
  • Materials are tested for biocompatibility and comply with ISO standards
  • Expired materials are discarded; inventory is rotated using FIFO method

2 Material Storage

  • Materials are stored in clean, dry, temperature-controlled environments
  • Contaminated or damaged materials are isolated and properly disposed
  • Material lot numbers are tracked for traceability

8. Dental Prosthetic Cleaning and Finishing

1 Post-Fabrication Cleaning

All completed restorations undergo thorough cleaning:

  1. Ultrasonic cleaning: To remove dust and debris
  2. Rinsing: Under running water with mild detergent
  3. Drying: Air-dried or dried with lint-free cloth
  4. Disinfection: Final spray disinfection if required

2 Quality Inspection

  • Restorations are inspected for cleanliness and absence of contamination
  • Any visible contamination requires re-cleaning and re-disinfection

9. Packaging and Dispatch

1 Sterile Packaging

  • Completed cases are packaged in sterile, sealed containers
  • Packaging materials are medical-grade and latex-free
  • Case number and material information are included with each package

2 Transportation

  • Cases are transported in dedicated, clean containers
  • Courier partners are briefed on proper handling to prevent contamination

10. Waste Management and Disposal

1 Contaminated Waste

All contaminated materials (used impressions, swabs, gauze) are treated as biomedical waste:

  • Segregated into appropriate color-coded bins (yellow for biomedical, red for sharp, black for general)
  • Disposed through authorized biomedical waste management facilities
  • Compliance with local municipal solid waste management rules

2 Sharp Waste

  • Used burs, broken instruments, and sharp debris are placed in puncture-proof containers
  • Disposed as per biomedical waste regulations

11. Staff Training and Competency

All laboratory staff receive comprehensive infection control training:

  • Initial Training: All new staff receive mandatory infection control orientation
  • Annual Refresher: Infection control protocols reviewed and updated annually
  • Competency Assessment: Staff are assessed annually on infection control compliance
  • Documentation: Training records are maintained for all staff members

12. Monitoring and Compliance

1 Regular Audits

  • Monthly internal audits of infection control procedures
  • Quarterly review of compliance documentation
  • Annual third-party inspection and certification

2 Corrective Actions

Any identified non-compliance is immediately corrected:

  • Root cause analysis is performed
  • Corrective and preventive action (CAPA) plan is implemented
  • Follow-up monitoring ensures sustained compliance

13. Incident Reporting

In the event of a potential infection control breach (needle stick, chemical splash, contamination exposure):

  1. Immediate first aid and decontamination
  2. Incident documentation within 24 hours
  3. Medical evaluation if required
  4. Root cause investigation and corrective action

14. Clients’ Responsibility

Clients must follow these practices to maintain infection control:

  • Impressions and models must be disinfected at the source (clinical setting) before shipment
  • Packaging should protect the case from contamination during courier transit
  • Received cases should be inspected for contamination and re-disinfected before chairside use if needed
  • Proper insertion technique and post-insertion care instructions should be provided to patients

15. Contact for Infection Control Concerns

For infection control inquiries, concerns, or compliance questions:

  • Email: replicadentallab@gmail.com
  • Phone: +91 9408844000
  • Address: 108 Sankalp Avenue, above Bank of Baroda, Station Road, Sayan, Surat, Gujarat 395001
  • Website: https://replicadental.com/