Core Principles and Regulatory Framework

1. Core Driving Force

Consumer safety and product stability. The goal is preventing product spoilage and deterioration caused by microbial and foreign matter contamination, and the potential for skin irritation or infection in consumers.

2. Regulatory Benchmark

Adherence to ISO 22716 (Cosmetics GMP) and national regulations (such as EU EC 1223/2009). The stringency is lower than pharmaceutical GMP, but far higher than ordinary industrial workshops.

3. Key Areas of Contamination Control

  • Microorganisms: Bacteria, molds, and yeasts are the main culprits causing product spoilage and toxin production.
  • Foreign Matter & Particles: Hair, dust, packaging debris, etc., affecting product appearance, feel, and consumer confidence.
  • Cross-contamination: Mutual contamination between different products and different fragrances/colorants.

Core Design Principle: Risk-Based Zone Control

Not the entire factory is subject to high standards, but rather key processes with high exposure risks are given priority protection.

Cosmetic Cleanroom Core Equipment List

This configuration is presented as an example to meet the requirements of the core filling area for emulsion/cream products.

A. Air Handling and Environmental Control Systems

1. Air Purification

  • Filling Room (Core): High-efficiency air supply diffusers or FFUs used to ensure air change rate ≥20 times/hour. Cleanliness level: ISO 7 (Class 10,000) under dynamic conditions or higher.
  • Other Clean Areas: High or medium-efficiency filters, with air change rate ≥15 times/hour.
Objective Microorganisms and particles are controlled through the principle of dilution. The filling area is the core area and requires sufficient ventilation.

2. Temperature and Humidity Control

  • Temperature: Generally controlled between 18-26°C.
  • Humidity: Critical control! Usually ≤65% RH (lower in southern regions, e.g., ≤55%), to prevent mold growth and moisture absorption.
Objective Low temperature and low humidity inhibit microbial growth while also ensuring the stability of certain products (such as pressed powder).

3. Pressure Gradient

  • Core Principle: Cleanliness levels decrease from high to low, with a gradual decrease in pressure difference.
  • Requirement: Maintain a positive pressure of ≥5-10 Pa. The filling room maintains positive pressure relative to the adjacent corridor/buffer room.
Objective Ensure that airflow flows from the high-cleanliness area to the low-cleanliness area to prevent contaminated air from flowing back.

4. Fresh Air and Exhaust Air

  • Fresh Air Supply: Sufficient supply to meet personnel needs and maintain positive pressure.
  • Local Exhaust Ventilation: Exhaust hoods installed in weighing rooms, sterilization rooms, and powder filling areas to prevent contaminant spread.
Objective Ensure good air quality by promptly removing heat, humidity, and sources of pollution.

B. Enclosure Structures and Material Management

1. Surface Material

  • Requirements: Smooth, wear-resistant, corrosion-resistant, easy to clean, non-absorbent, and resistant to mold growth.
  • Walls: Ceramic tiles, color-coated steel panels, or antibacterial coatings.
  • Floors: Epoxy self-leveling coatings or PVC sheet materials.
  • Ceilings: Color-coated steel panels or gypsum boards with anti-mold paint.
  • Details: All interior and exterior corners are rounded.

2. Personnel Purification

  • Basic Procedure: Change shoes → Change clothes (clean work uniform) → Wash and disinfect hands → Air shower (optional) → Enter clean area.
  • Note: Personnel in the core filling area require even stricter procedures.

3. Material Purification

  • Raw Materials: Outer packaging stripped in external cleaning room; transferred via pass-through window.
  • Inner Packaging: Bottles, cans, and lids must be cleaned and disinfected (UV light, ozone, or alcohol) before entering the clean area.
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