Equipment needed in serum packaging area

In the production of cosmetics, especially serums - a highly sensitive product line, the packaging area plays an extremely important role in ensuring quality and purity. Choosing the right equipment needed in the serum packaging area helps to strictly control factors such as dust, microorganisms and humidity, while maintaining an environment that meets GMP or ISO 22716 standards. A properly designed and arranged equipment system not only prevents cross-contamination but also optimizes the process of filling, capping, labeling and product testing - ensuring that each bottle of serum meets the highest standards before going to market.

1. Why must the serum packaging area be strictly controlled?

The serum packaging area is not only the final stage of the production line but also the place that determines the final quality of the product before reaching consumers. Strict control in this area is a mandatory requirement in cosmetic factories that meet GMP or ISO 22716 standards.

Packaging stage - the "final safeguard" for serum quality
Each bottle of serum must undergo filling, capping, labeling, and final inspection before release. Without a clean environment and proper equipment, even a microscopic dust particle or a single microorganism can:

• Spoil the entire product batch
• Cause microbial cross-contamination
• Destabilize active ingredients in the serum (e.g., vitamin C, retinol, peptides, which are highly sensitive)

Common risks in the serum packaging area

What do GMP and ISO 22716 standards require in the packaging area?
According to GMP guidelines and ISO 22716 (Good Manufacturing Practices for cosmetics), the packaging area must:

• Be a cleanroom with ISO 7-8 classification or equivalent
• Control pressure differentials, maintaining positive pressure against adjacent areas
• Implement unidirectional movement to prevent cross-contamination
• Be equipped with air filtration, proper lighting, microbiological control, and dust protection systems

Complying with these regulations not only helps factories pass inspections but also ensures the safety, stability, and consistency of cosmetic products before reaching end-users.

2. List of essential equipment in the serum packaging area

In the serum packaging area, each piece of equipment not only serves a technical function but also contributes to environmental control and compliance with GMP and ISO 22716 standards. Below is a list of essential equipment, their main functions, and why they are needed:

3. Recommended layout for equipment in the serum packaging area

Designing the layout of the packaging area plays a crucial role in maintaining a clean environment, preventing cross-contamination, and ensuring GMP-compliant unidirectional flow. Below are the key principles and suggested equipment placement:

Personnel and material flow: separated and unidirectional

• Personnel flow: Changing room → air shower → airlock → packaging room
• Material flow: Packaging materials from warehouse → pass box → packaging room
• Finished product flow: Outbound via return pass box or auxiliary airlock

Key principle: There must be no intersection between personnel and material flows. All movement must follow the direction from clean → cleaner zones.

Typical equipment layout

Key layout rules

• Air Shower should always be at the start of the line: decontaminate personnel before entry
• Pass Box must be placed between rooms of different cleanliness levels
• FFU and Laminar Flow Cabinet must be at filling/capping stations - the most sensitive areas
• Avoid placing obstacles under FFU clean airflow paths

See more: Equipment required in VCR's GMP-standard serum packaging area

4. Notes when selecting equipment for cosmetic packaging areas

Choosing the right equipment for the serum packaging area not only affects production efficiency but also determines the factory’s ability to meet GMP/ISO standards. Key criteria to consider include:

1. Prioritize equipment certified for GMP and ISO 22716

• Equipment must meet international cleanroom standards such as:
• ISO 14644 (cleanroom classification)
• ISO 22716 (cosmetic GMP)
• CE, RoHS, FDA if exporting
• Should provide COC/COD, technical drawings, and SOPs

2. Equipment design must be hygienic - antimicrobial - low crevice

• Prefer stainless steel 304 or 316L, smooth and non-dust-absorbing surfaces
• Corners should be rounded, no deep gaps to prevent microbial buildup
• Easy disassembly and maintenance, rust-free materials

3. Integrate environmental monitoring systems when needed

Depending on the factory’s needs, consider installing:

• Differential pressure sensors: monitor positive pressure
• Airborne particle/microbial counters: fixed or portable
• Alarms for pressure drops or interlock malfunctions

Summary of equipment selection criteria:

5. Frequently asked questions about equipment in the serum packaging area

1. Is using FFU mandatory in the serum packaging area?

It is not mandatory under ISO 22716, but strongly recommended if ISO 5-7 cleanliness is required. Especially at filling or capping stations - where microbial contamination is most likely - FFUs maintain clean airflow and reduce airborne risks.

2. Should I choose a mechanical or electronic Pass Box for cosmetics?

Both types serve the same basic function. However:

• Electronic Pass Box is ideal for high-frequency operations and automated workflows
• Mechanical Pass Box is more cost-effective, suitable for low-traffic areas
• Optional: consider UV or ionized Pass Boxes for enhanced microbial control

3. Is pressure control necessary in the packaging room?

Yes. Maintaining positive pressure is mandatory under GMP/ISO for cosmetic cleanrooms. Higher pressure relative to adjacent rooms helps:

• Prevent contaminated air from entering
• Protect the product from external microbial threats

6. Are you building a compliant serum packaging area?

Choosing the right equipment and designing a compliant layout is not just about production-it is critical to achieving GMP/ISO 22716 certification.

VCR - a leading provider of cleanroom equipment solutions for the cosmetics industry - is ready to assist you with consultation, layout design, equipment supply, and GMP inspection support.

Contact us today for 1:1 expert consultation:

Hotline: 090.123.9008
Email: [email protected]
Website: https://phongsachmypham.com/

Diep VCR