Common mistakes when investing in cosmetic clean rooms

1. The booming cosmetics industry - but not everyone is ready for cleanrooms

Vietnam's cosmetics market is experiencing strong growth driven by rising beauty demands, the trend of private label production, and increasing export opportunities. However, in order for cosmetic products to be legally distributed and competitive, factories must comply with standards such as GMP (Good Manufacturing Practices) or ISO 22716.

Among these requirements, the cleanroom is the core facility where critical processes like filling, packaging, and quality control take place. These areas must be strictly controlled for microorganisms, dust, temperature, and humidity. Even small deviations in design or operation can lead to:

• Contaminated products and rejected batches
• Failure to pass inspection by the Ministry of Health
• Ineligibility for GMP/ISO certification
• Costly investment losses and delays in market launch

In reality, many investors lack experience or choose the wrong cleanroom contractor - leading to a series of costly mistakes that could have been avoided from the outset.

2. 7 critical mistakes when investing in cleanrooms for cosmetic factories

Below are common mistakes many cosmetic businesses - especially SMEs - make when building cleanrooms, resulting in delays, extra costs, and failure to meet regulatory standards:

Mistake 1: Not identifying the correct standard to follow

Many confuse GMP, cGMP, and ISO 22716.
Lack of clarity leads to incorrect design and configurations.
Consequence: Failed inspections, requiring redesign or reconstruction.
Recommendation: Identify your export goals and target market early to select the correct regulatory framework.

Mistake 2: Poor layout planning not based on the production flow

Improper layout increases the risk of cross-contamination.
Example: The filling area is placed too close to the raw material or finished goods storage.
Solution: Design a unidirectional workflow with clearly separated zones (raw material → filling → packaging → storage).

Mistake 3: Lack of buffer zones and airlocks at gowning areas

Some facilities only have one gowning room, which cannot effectively control particles or microbes.
No interlock system means both doors can open simultaneously, causing pressure loss.
Solution: Design at least 3 gowning rooms (dirty → intermediate → clean), and use interlock door systems to control entry flow.

Mistake 4: Choosing the wrong cleanroom equipment

Using a Pass Box without UV light or HEPA filters increases contamination risks.
Using an FFU with incorrect filter grade or insufficient airflow means failing to meet ISO cleanroom classification.

Mistake 5: Inadequate control of temperature, humidity, and pressure

Some cosmetic products (like serums or creams) are highly sensitive to environmental conditions.
Without sensors or proper HVAC systems, product quality may be compromised.
Solution:

• Install sensors for differential pressure, temperature, and humidity
• Use specialized air conditioning integrated with real-time monitoring systems

Mistake 6: Lack of GMP training for staff

Operators are unfamiliar with gowning procedures and clean/dirty zone separation.
No clear SOPs lead to procedural errors and contamination.
Recommendation:

• Develop detailed SOPs for each step
• Conduct regular training sessions and practical assessments

Mistake 7: Choosing a contractor without cosmetic cleanroom experience

Some builders apply standards for pharmaceuticals or food, which are not optimized for cosmetic manufacturing.
Result: Wrong materials, incorrect equipment, multiple costly revisions, and failed audits.
Solution: Work with contractors who specialize in cosmetic cleanrooms and understand ISO 22716, GMP, and the unique challenges of cosmetics (e.g., odor, microbiological risk, humidity).

3. Mistakes - Consequences - Solutions in Building Cosmetic Cleanrooms

4. Frequently Asked Questions About Cosmetic Cleanrooms

1. Which standards must a cosmetic cleanroom comply with?
   Depending on the scale and target market, cosmetic cleanrooms may need to meet ISO 22716, GMP, or cGMP. ISO 22716 is the most commonly used standard for domestic and export-oriented cosmetic manufacturers.
2. What areas are required in a compliant cosmetic cleanroom?
   A standard cosmetic cleanroom typically includes:

• Gowning rooms (at least 2-3 zones: dirty, intermediate, clean)
• Filling and packaging areas
• Storage for raw materials and finished products
• Airlocks for material transfer
• Environmental control systems for temperature, humidity, and pressure

3. Is a Pass Box necessary in cosmetic cleanrooms?
   Yes. Pass Boxes allow the transfer of materials between rooms without opening doors, reducing the risk of microbial cross-contamination and maintaining pressure stability. For cosmetics, UV or HEPA-equipped Pass Boxes are recommended.
4. How do I know which equipment is suitable for each area?
   Each functional area has specific requirements:

• Filling area: use FFUs with H13-H14 grade filters
• Packaging area: requires clean lighting and dust removal
• Transfer areas: use Pass Boxes and interlocks
  It is best to consult with cleanroom contractors specializing in cosmetics, such as VCR, to choose the right equipment and optimize costs.

5. Why do some factories fail audits even after building a cleanroom?
   Common reasons include:

• Choosing the wrong standard (e.g., using GMP for pharmaceuticals instead of ISO 22716)
• Poor design not based on unidirectional flow
• Using non-compliant equipment
• Lack of GMP training for staff
  Even with significant investment, failing to get proper guidance from the beginning can lead to failed audits.

5. Are you planning to build a cosmetic cleanroom?

Don't let early mistakes cost you money, delay your project, or cause audit failures. Let VCR’s GMP-certified engineering team guide you from consultation to construction, ensuring compliance with ISO 22716 and alignment with actual production needs.

• Free consultation for layout and equipment configuration
• Optimized layout suggestions based on your production process
• Quotation for compliant equipment available in stock

Contact us today:

Hotline: 090.123.9008

Email: [email protected]

Website: https://phongsachmypham.com/

Diep VCR