In the cosmetic production industry, adherence to regulatory standards has emerged as the new pillar of success, especially with the impending changes being enacted by MoCRA. With these significant shifts on the horizon, navigating the complexities of federal medical compliance can be daunting. However, equipped with the right knowledge and guidelines, cosmetic manufacturers can proactively prepare for these impending changes and ensure seamless adaptation to new regulatory requirements.
Regulatory Compliance
Regulatory compliance is the core of every cosmetic production facility. Adhering to standards like Good Manufacturing Practices (GMP), ISO 22716, and regional regulations is fundamental. ISO 22716, in particular, mandates that most cosmetic products must be bottled or filled within a cleanroom environment, similar to pharmaceutical requirements for ingestible products.
Some of the cosmetic items that are covered under this ISO standard include:
- Perfumes
- Face masks
- Washing gels
- Mascara
- Concealer
- Lipstick
- Creams
ISO 22716 and GMP establish a framework to ensure consistency and safety during production, so incorporating new GMP guidance from MoCRA is essential.
Classification
Selecting the right cleanroom classification is important when setting up an ideal environment for cosmetic production. The type of cosmetics being made determines the necessary level of cleanliness, guiding decisions on air filtration, particulate control, and environmental monitoring.
Most cosmetic cleanrooms are categorized as Class D or ISO 8, offering control over critical factors like pressure, humidity, temperature, and airborne particle concentration.
These cleanrooms are extensively used in the cosmetic industry and utilize specialized HEPA filters, doors, ceilings, partitions, and floors. Their primary function is to help effectively minimize the entry of particles into the cosmetics packaging area.
Design and Construction
In the cosmetic industry, utilizing a cleanroom involves design and construction. There are different types of cleanrooms, including modular and hard-side options, and the category of design and construction of these spaces uphold cleanliness standards. For example, ISO 8 cleanrooms, or Class 100,00 cleanrooms, are equipped with HEPA filtration systems that cover 4-5% of the room to catch dust and other particles. The room’s air is changed at least 20 times every hour to keep it clean.
Cleanroom requirements such as smooth surfaces, sealed floors, and efficient ventilation systems are important for easy cleaning and minimizing contamination risks.
Personnel Training
Personnel in cleanroom environments undergo rigorous training on hygiene protocols and gowning procedures to prevent the accidental introduction of contaminants into the production process. This includes mastering proper handwashing techniques, adhering to gowning practices, and maintaining appropriate behavior within the cleanroom.
Basic requirements for maintaining good preparation hygiene include:
- Avoid make-up, painted nails, jewellery, or piercings.
- Prohibiting personal electronic devices such as phones or computers in the controlled area.
- Refraining from bringing personal clothing, food, or drinks into the controlled area.
- Maintaining a high level of personal hygiene and strictly following correct hand washing and disinfection techniques.
Following OSHA regulations, it is strongly advised to provide each staff member with their own pair of safety glasses when there is a risk of chemical or drug splashes. Personnel responsible for cleaning must don appropriate protective gear, including sock covers, bouffant caps, masks, safety glasses, gowns or frocks, and beard covers if necessary.
Cleaning and Disinfection
Clean equipment forms the foundation of cosmetic production. Regular daily, weekly, and spot cleaning, along with routine maintenance, are necessary practices for preventing cross-contamination and maintaining product quality. Utilizing dedicated equipment solely within the cleanroom environment significantly reduces the risk of introducing foreign particles or microbes into cosmetic formulations.
Cleaning and disinfection procedures should generally start from the dirtiest area and progress to the cleanest, moving from an ISO Class 6 or 7 cleanroom to the ISO Class 8– top to bottom. Daily cleanings are best performed at the end of the day to prepare for the next shift.
To ensure effective cleaning and prevent cross-contamination protocols:
- Use cleaning materials exclusively designated for specific areas.
- Avoid using equipment for cleaning walls and ceilings on floors or outside designated areas.
- Opt for low-lint cleaning tools crafted from synthetic microfibers in ISO class 5 to 8 areas.
An extensive cleaning and standard operating protocol is indispensable for maintaining cleanliness in cosmetic production facilities. Create a checklist of cleaning and disinfection procedures where all surfaces, equipment, and tools must be regularly cleaned and disinfected using approved agents suitable for cleanroom use.
Environmental Monitoring
Environmental monitoring of a cleanroom includes temperature monitoring, particle counts, and microbial testing to assess room cleanliness. This centralized control, also known as a building management system (BMS) or building automation system (BAS), ensures rigorous oversight of cleanroom conditions.
The monitoring system collects data at predefined intervals, triggering alerts if particle thresholds are exceeded without corrections. Conducting several days of environmental monitoring after initial cleaning will confirm adequate cleanliness.
Gathering this data over months or years proves compliance with acceptable parameters for the production process.
Environmental monitoring programs should evolve with changes in the production area, such as introducing new products or modifying processes, to ensure effectiveness. Dr Tim Sandle notes, “An expectation of zero contamination at all locations during every aseptic processing operation is technically not possible and thus is unrealistic.”
Documentation and Record-keeping
Documentation remains critical for maintaining cleanliness standards in cosmetic manufacturing. Detailed records of cleaning schedules, environmental monitoring results, personnel training, and deviations from standard procedures are essential for audits and regulatory compliance.
These records provide evidence of adherence to industry standards and guidelines and enable manufacturers to track and evaluate the effectiveness of their cleanliness protocols, identify improvement areas, and demonstrate accountability to regulatory bodies and consumers.
Choose Dycem for Enhanced Contamination Control
Dycem mats help maintain a pristine cleanroom environment by being strategically positioned at entry points to capture and retain particles from shoes and equipment wheels. Regular cleaning ensures the effectiveness of Dycem in reducing airborne and surface contaminants. This integrated approach adds an extra layer of protection, reinforcing the commitment to upholding the highest standards of cleanliness within the cleanroom facility.
Contact us today to improve your contamination control. Dycem supports good manufacturing practices and contamination monitoring for the safety of your products, staff, and customers, regardless of your industry.