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Topical antimicrobial agents are indispensable in the management of burn wounds, skin ulcers, trauma injuries, and post-surgical sites. Among the most trusted combinations in wound care is Silver Sulphadiazine and Chlorhexidine, known for their broad-spectrum antimicrobial activity and ability to promote healing while preventing secondary infections. Used in hospitals, trauma care units, and first-aid applications worldwide, this dual-agent formulation represents a cornerstone of topical infection management.
At BluepillExpress, we provide comprehensive third-party manufacturing services for Silver Sulphadiazine and Chlorhexidine-based products, adhering to WHO-GMP, ISO 9001:2015, and national pharmacopeial standards. We offer customizable strengths, packaging formats, and full regulatory support for pharmaceutical companies, hospital supply vendors, NGOs, and global health programs seeking a reliable partner for topical antimicrobials.
Product Overview: Silver Sulphadiazine and Chlorhexidine
Silver Sulphadiazine is a sulfonamide-based topical antimicrobial that releases silver ions in a controlled manner, which disrupt bacterial cell walls and DNA, effectively inhibiting the growth of a wide range of Gram-positive and Gram-negative organisms.
Chlorhexidine, a cationic biguanide, exhibits broad-spectrum antiseptic activity by targeting the microbial cell membrane, causing cell lysis and death. It is especially effective against bacteria, some fungi, and viruses.
Therapeutic Synergy:
When combined, these two agents deliver dual-action wound protection—silver’s bactericidal depth and chlorhexidine’s surface antimicrobial defense—making this formulation ideal for serious burns, ulcers, and high-risk wounds.
Common Indications:
- First- and second-degree burns
- Skin ulcers and bedsores (pressure ulcers)
- Surgical incisions and trauma wounds
- Donor site dressings in skin graft procedures
- Minor cuts, abrasions, and infected wounds
Why Choose BluepillExpress for Manufacturing?
1. WHO-GMP Certified Manufacturing Facilities
Our production plants are fully compliant with WHO-GMP, Schedule M, and ISO 9001:2015 standards, ensuring that every batch of Silver Sulphadiazine and Chlorhexidine meets international quality expectations.
- Sterile and semi-sterile topical preparation areas
- Validated stainless steel mixing vessels
- HEPA-filtered environments for sensitive product handling
- Separate zones for antibiotic-based formulations
2. Multiple Dosage Forms and Packaging Flexibility
We manufacture a variety of Silver Sulphadiazine + Chlorhexidine formulations including:
- Topical Creams
- Antimicrobial Gels
- Wound Care Ointments
- Sachet-based single-use packs
- Tubes and jars for clinical and OTC use
Available Strengths (customizable):
- Silver Sulphadiazine 1% w/w + Chlorhexidine Gluconate 0.2% or 0.5% w/w
- Other concentrations can be developed based on buyer specification and regulatory approvals
3. End-to-End Third-Party Manufacturing Solutions
Our turnkey services include:
- Product development and formulation stability studies
- Analytical method development and validation
- Manufacturing, batch testing, and stability documentation
- Custom packaging, private labeling, and multilingual inserts
- CTD/eCTD dossier preparation for international registrations
Technical Specifications
| Product Name | Silver Sulphadiazine + Chlorhexidine Topical Formulation |
|---|---|
| Dosage Forms | Cream, Gel, Ointment |
| Strengths | Silver Sulphadiazine 1% + Chlorhexidine 0.2%/0.5% |
| Packaging Options | Tubes (15g, 30g, 50g, 100g), Sachets, Jars |
| Pharmacopoeial Standards | IP / BP / USP / Custom |
| Route of Administration | Topical |
| Shelf Life | 24 to 36 months |
| Storage Conditions | Store in a cool, dry place below 25°C |
Therapeutic Applications and Clinical Use
1. Burn Wound Management
Silver Sulphadiazine suppresses bacterial colonization in burn wounds, while Chlorhexidine enhances surface antisepsis. Together, they prevent sepsis, promote healing, and reduce scarring.
2. Surgical and Trauma Wound Care
Post-surgical incisions and traumatic skin injuries are prone to infection. This formulation provides dual-layer antimicrobial protection, facilitating faster recovery and reduced hospital stay.
3. Chronic Ulcers and Bedsores
Patients with immobility or poor circulation often suffer from pressure ulcers. The combined formulation reduces microbial load and promotes granulation tissue formation in chronic wounds.
4. Skin Graft Sites
Used as a dressing on donor or recipient sites post-grafting, it helps maintain sterility and hydration while minimizing rejection risk due to infection.
5. OTC and First Aid Use
The formulation is ideal for inclusion in first-aid kits for treating minor burns, cuts, and abrasions.
Manufacturing Process Overview
BluepillExpress employs a robust, validated, and quality-controlled process for every batch of Silver Sulphadiazine and Chlorhexidine.
1. Raw Material Handling and Dispensing
- Verified sourcing of API from certified vendors
- In-house testing for assay, identity, and microbiological limits
- Weighing and dispensing in GMP-compliant environments
2. Emulsification and Mixing
- APIs and excipients are emulsified using stainless steel homogenizers
- Temperature-controlled mixing ensures uniform distribution and stability
- Preservatives and emollients added to enhance formulation effectiveness and feel
3. Quality Testing (In-Process)
- Viscosity, pH, microbial control, and consistency tests
- In-process QA sampling for every batch
- Fill weight and packaging uniformity monitored
4. Primary and Secondary Packaging
- Filled in aluminum or laminate tubes with tamper-evident caps
- Optional sachet filling for institutional use
- Carton packaging with printed inserts, barcoding, and branding
5. Final Quality Control
- Analytical tests for Silver and Chlorhexidine concentration
- Microbial limit testing
- Stability testing under ICH conditions
- Visual inspection for homogeneity and packaging defects
Quality Assurance and Regulatory Support
Every product manufactured by BluepillExpress is released only after passing a multi-level quality assurance review:
Key Quality Control Tests:
- Assay (active content)
- Uniformity of weight and content
- Sterility and microbiological tests
- Viscosity and spreadability testing
- pH and appearance monitoring
- Stability testing (real-time and accelerated)
Documentation Provided:
- Certificate of Analysis (CoA)
- Batch Manufacturing Record (BMR)
- Product Specifications Sheet
- Method of Analysis (MoA)
- CTD or ACTD Dossiers (on request)
We provide technical support for product registration, including:
- Country-specific labeling and artwork
- Product registration dossiers
- Certificates of Pharmaceutical Product (CoPP)
- Free Sale Certificates (FSC)
- Certificate of Origin (COO)
Packaging and Customization Options
BluepillExpress offers packaging solutions that ensure ease of use, brand differentiation, and product stability:
- Laminated or aluminum tubes: 15g, 30g, 50g, 100g
- Sachets: For institutional or single-use formats
- Wide-mouth jars: For hospital dispensing
- Secondary cartons with brand design and multi-language instructions
- Tamper-evident, barcoded, and serialized packs for regulated markets
We offer private labeling and custom branding support, including assistance with artwork design and multilingual compliance.
Export and Global Supply Chain Capability
BluepillExpress is a recognized exporter of topical antimicrobial products, including Silver Sulphadiazine and Chlorhexidine formulations. We serve clients in:
- Africa: Kenya, Nigeria, Ghana, Uganda, Ethiopia
- Asia: Sri Lanka, Myanmar, Nepal, Bangladesh
- Middle East: Iraq, Yemen, UAE, Saudi Arabia
- Latin America: Bolivia, Honduras, Nicaragua
- Europe and CIS: Select markets upon request
Export Support Services:
- Support for registration dossiers (CTD format)
- Certificates for import customs clearance
- Regulatory compliance for labeling and shelf-life documentation
- Third-party logistics (3PL) and international shipping coordination
We also support government procurement tenders, NGO partnerships, and UNICEF/UNFPA-driven programs.
Target Clients and Use Cases
Our third-party manufacturing solutions are designed to serve:
- Generic pharmaceutical brands and OTC product lines
- Institutional suppliers and hospital distributors
- NGOs and global health missions
- Emergency medical kit manufacturers
- First-aid product resellers and online pharmacies
- Public health agencies and disaster response units
Whether your goal is high-volume supply or low-MOQ private labels, BluepillExpress has the capability and agility to meet your demands.
Research & Development Services
We also offer custom R&D for specialized topical antimicrobial formulations:
- Heat-stable variants for tropical environments
- Combination products (e.g., with lidocaine or aloe extract)
- Fast-absorbing or hydrogel formats
- Pediatric or fragrance-free versions
- Technology transfer for proprietary brands
Our R&D team supports pilot batch development, scale-up trials, bioequivalence assessments, and method validation.
Sustainability and Ethical Practices
As a modern pharmaceutical manufacturer, BluepillExpress is committed to environmental responsibility and ethical operations, including:
- Zero Liquid Discharge (ZLD) facilities
- Safe waste handling for sulfonamide-containing products
- No use of animal testing
- Energy-efficient production infrastructure
- Ethical labor and workplace safety standards
We align our processes with WHO and UN sustainability goals, particularly in wound care, infection control, and maternal health.
Confidentiality and Business Ethics
We take client confidentiality seriously and ensure:
- Signed Non-Disclosure Agreements (NDAs)
- Intellectual property protection
- Brand exclusivity (on agreement)
- Transparent pricing and batch tracking
- Post-manufacturing customer service and support
Our goal is to build long-term partnerships based on quality, integrity, and innovation.
Conclusion
Silver Sulphadiazine and Chlorhexidine is a vital topical antimicrobial combination that addresses serious concerns in wound care, burn management, and surgical recovery. Its reliable efficacy, ease of application, and cost-effectiveness make it a valuable product in both hospital and community healthcare settings.
With state-of-the-art facilities, a rigorous quality control system, and a deep understanding of international regulatory requirements, BluepillExpress is your trusted partner for third-party manufacturing of Silver Sulphadiazine and Chlorhexidine formulations.
