SLS Free Capsules

SLS Free Capsules, Sodium lauryl sulfate(SLS)free,meeting the special needs of the Japanese market,with exclusive formula and process technology.

▶Equipped with advanced PTS production lines, featuring an intelligent sol-gel system, automatic viscosity adjustment equipment, Automatic Guided Vehicle (AGV) system, and vacuum pipeline for capsule transmission. The entire process is fully automated and traceable, ensuring core process control and superior product quality.

 

▶Ethylene oxide-free sterilization is achieved through fully automated operations, rigorous indoor cleaning protocols, comprehensive quality monitoring, and constant temperature and humidity control throughout production.

 

▶The air purification system is built by international brands such as Carrier, AL-KO, and Ingersoll Rand. The air change rate is 40 times/hour in the smart workshop to ensure the degree of air purification and the constant temperature and humidity in the environment;

 

▶The size of new capsule mold matches with existing mainstream filling machine. Professional technical service team for the service from pre-sale to after-sales to help to improve capsule filling rate.

We strictly follow international GMP standards for pharmaceutical excipients and have passed ISO 9001 Quality Management System Certification. Upholding scientific, standardized, and high-quality practices is our core responsibility.

Follow cGMP to organize production and quality management, establishing a quality assurance system, and the laboratory will carry out CNAS certification.

Quality objectives: product market sampling rate of 100% pass rate, significant quality and safety accidents to zero, leading products and services industry standards

Our product complies with the standards of the Chinese Pharmacopoeia and has passed international certifications such as HALAL, Kosher, FDA, ISO9001 and ISO22000.

1.Excellent lead time with sufficient supply quantity;

2.Response time to quality problems: within 12 hours, the sales, technical and after-sales departments will make a joint response;

3.Provide customers with free training of filling machine maintenance, operation and capsule inspection knowledge, to better solve customers' actual problems;

4.Provide filling machine installation, debugging, repair and maintenance services free of charge, and assist customers in ordering filling machine spare parts;

5.Free samples for testing;

6.Comprehensive after-sales technical support;

7.Customized capsules according to the characteristics of customer powder.

Packaging

● PE bag+Aluminum foil bag+Six surface foam board+5 ply corrugated Carton;

● Carton size 60x73x40cm,volume 0.18 cubic meters,gross weight is about 15kgs per box ;

● 20' Refrigerator Container : 140 cartons empty capsules;

● 40' Refrigerator Container: 345 cartons empty capsules.

 

Storage

1.SLS Free Capsules should be stored in the room with the temperature between 10-25°C and the relative humidity of 35-65%;

2.Capsule carton should be kept away from walls and a certain distance from the floor to avoid moisture;

3.Avoid direct sunshine,keep away from heat generation and water sources.

 

Available for customization according to the customer's requirements.

Regulations and Market Applications of SLS-Free Capsules

As the demand for safer, cleaner, and more natural pharmaceutical and nutraceutical products grows, Sodium Lauryl Sulfate (SLS)-a commonly used surfactant and emulsifier-has come under scrutiny for its potential health and irritancy concerns. This shift in consumer expectations and regulatory pressure has led to the growing adoption of SLS-free capsules across global markets.

Regulatory Overview

European Union (EU)

The European Medicines Agency (EMA) and European Chemicals Agency (ECHA) have flagged SLS as a potential irritant to the skin, eyes, and respiratory tract, and its inclusion in pharmaceutical products must be justified under the principles of ICH Q3C (guideline on residual solvents) and excipient safety. In particular, EMA's 2021 update on excipient labeling requires more transparent labeling of known irritants and allergens-including SLS-within drug product leaflets and technical documentation.

While SLS is still permitted in EU pharmaceutical applications, its presence must be disclosed and scientifically justified, especially in oral or topical formulations. This has prompted many manufacturers to reformulate capsules and avoid SLS altogether, particularly when producing sensitive formulations like pediatric or geriatric medicines.

United States (FDA)

The U.S. Food and Drug Administration (FDA) still lists SLS as Generally Recognized As Safe (GRAS) for limited use in pharmaceuticals and foods. However, increasing consumer sensitivity and rising demand for clean-label products have led to a market-driven reduction in its usage.

Other Markets

Canada, Australia, and South Korea maintain similar cautionary stances, requiring clear labeling and dose-limitations on SLS. Regulatory bodies in the Middle East-particularly in Halal-certified markets-also show preference for SLS-free options to meet religious and ethical standards.

Market Applications

Pharmaceutical Industry

In capsule production, SLS is sometimes used in the lubrication process or as a wetting agent to improve capsule disintegration and dissolution. However, concerns over mucosal irritation, hypersensitivity reactions, and its synthetic nature have driven capsule manufacturers to eliminate SLS altogether.

SLS-free capsules are increasingly favored for:

Pediatric medicines

Geriatric and long-term use therapies

Sensitive patient populations

"Clean-label" or hypoallergenic product lines

Leading pharmaceutical brands are choosing SLS-free gelatin or HPMC capsules to meet both compliance and patient safety standards.

Nutraceuticals and Clean Label Products

The natural health supplement market is where SLS-free capsules have found their strongest demand. Consumers seeking organic, vegan, or non-GMO products are more likely to reject products containing synthetic surfactants like SLS. Nutraceutical companies are marketing "SLS-Free" as a value-added feature, often alongside "titanium dioxide-free" and "preservative-free" claims.

Export-Oriented Brands

Companies targeting EU, Middle Eastern, and premium Asian markets must align with local or religious standards that favor SLS-free formulations. Halal and Kosher certifications often prohibit or discourage the use of synthetic detergents like SLS, reinforcing the trend.

Conclusion

With health-conscious consumers demanding higher transparency and regulatory agencies pushing for safer formulations, SLS-free capsules represent the new standard for safety and trust. Whether driven by patient need, global compliance, or brand positioning, eliminating SLS from capsule formulations is both a proactive and strategic move for modern pharmaceutical and nutraceutical brands.

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