How to Produce Ceftriaxone Sodium and Sulbactam Sodium for Injection
                     rklifecare.com
INTRODUCTION 
In the world of parenteral pharmaceutical products, 
Ceftriaxone Sodium and Sulbactam Sodium for Injection 
stands out as a powerful combination used to combat a 
wide range of bacterial infections. This sterile injectable 
formulation combines the third-generation cephalosporin 
ceftriaxone with the beta-lactamase inhibitor sulbactam, 
increasing its efficacy against resistant organisms.
Manufacturing this formulation requires precision, 
regulatory compliance, a sterile environment, and a highly 
experienced technical team.
Experience in Dry 
Injection Manufacturing
Our Manufacturing 
Heritage
With decades of pharmaceutical manufacturing experience, we at R K Lifecare Inc. 
have developed a firm grasp on aseptic techniques, sterile formulation development 
and Good Manufacturing Practices (GMP). Our practical experience in handling beta-
lactam antibiotics, including third-generation cephalosporins such as ceftriaxone, is 
evident in our production results, market acceptance and regulatory compliance
Handling of Potent 
APIs
Given the allergenic and potent nature of cephalosporins, producing dry injections of ceftriaxone and sulbactam requires strict 
containment strategies. Our facility design includes:
• Dedicated beta-lactam blocks
• Class 100 (ISO 5) cleanroom environments for filling
• Validated air handling units (AHUs) with HEPA filters
• Dedicated HVAC systems
• Airlocks and pressure differentials
These ensure that cross-contamination risks are eliminated and product sterility is maintained at every stage.
EXPERTISE IN FORMULATION 
AND MANUFACTURING
Active Pharmaceutical Our R&D and QA teams 
Ingredients (API) Profile ensure both APIs:
• Meet pharmacopeial 
• Ceftriaxone Sodium (USP/IP/BP grade): A 
specifications
bactericidal agent with broad-spectrum 
activity. • Have low residual solvents
• Sulbactam Sodium (USP/IP/BP grade): A • Show desired microbiological 
beta-lactamase inhibitor that extends purity
Ceftriaxone’s spectrum against resistant • Exhibit correct particle size 
strains.
distribution for proper blending
 ratio is critical to preserve 
API Ratio Optimization the synergy between both 
agents.
The commonly used clinical formulation • Compatibility studies
is: • Moisture content analysis
• Stability studies under ICH 
• Ceftriaxone Sodium: 1000 mg guidelines
• Sulbactam Sodium: 500 mg • Pre-formulation trials for powder 
• OR behavior, flow properties, and 
• Ceftriaxone Sodium: 500 mg sterility retention
• Sulbactam Sodium: 250 mg
Raw Material Procurement and 
01 Testing• Identification (IR/UV)
• Assay (HPLC/UV)
• Water content (Karl Fischer)
• Sterility
• Microbial limits
• Heavy metals
02 Dispensing
• Carried out in a Class 100,000 (ISO 8) area
• Operators wear sterile gowning
• Ingredients are weighed using calibrated balances
• Dispensing is performed in reverse laminar airflow (RLAF) booths to minimize contamination
Step-by-Step 03 Dry Mixing and BlendingAfter weighing:
• APIs are transferred to a Rapid Mixer Granulator (RMG) or double cone blender
• Mixing duration and speed are validated
• Blend uniformity is tested using content uniformity assays
Manufacturing • In-process control (IPC) is performed to check for segregation, particle agglomeration, and flowability04 Sterile Filtration & Aseptic 
•TSorluation psrepfareatiron in Water for Injection (WFI)
• pH adjustment
Process • Sterile filtration using 0.22-micron filters• Transfer to sterile filling areaThis step must be conducted in Class 100 (ISO 5) zones under strict aseptic conditions.
05 Vial Washing and 
1S.Putrifiedr Wialteir z(PWa)tion
2.WFI
3.Compressed air
4.Drying with laminar airflow
Post-washing, vials are depyrogenated in hot-air tunnels at 320°C.
06 Sterile Powder 
•FMiixleldi pnowgder is filled using automatic sterile powder filling machines
• Nitrogen purging is applied before and after filling
• Fill weight consistency is checked every 15-30 minutes
• Class 100 environment is strictly maintained with restricted operator movement
07 Rubber Stoppering and Sealing
• Sterile rubber stoppers are placed immediately after filling
• Aluminum seals are crimped onto the vials using automated sealing machines
• Visual inspection is performed under white and black light backgrounds to identify particulate matter, cracks, or 
foreign particles
Lyophilization 
In case of lyophilized formulation:
• Vials are pre-frozen at -40°C
• Transferred to a lyophilizer for sublimation under vacuum
• Final moisture content is targeted to be