Advanced Pharmaceutical
Manufacturing Capabilities
State-of-the-art facilities, cutting-edge technology, and comprehensive capabilities designed to meet the most demanding pharmaceutical manufacturing and development requirements.
Comprehensive Capabilities Overview
Our integrated pharmaceutical capabilities span the entire product lifecycle, from initial development through commercial manufacturing and distribution.
sq ft Manufacturing Space
ISO Class 7 Cleanrooms
Quality Monitoring
Analytical Methods
Manufacturing Excellence
State-of-the-art cGMP manufacturing facilities with advanced automation and quality control systems.
- Sterile and non-sterile production lines
- Automated dispensing systems
- Environmental monitoring
- Batch documentation systems
Laboratory Services
Comprehensive analytical and microbiological testing capabilities supporting all pharmaceutical operations.
- USP method validation
- Stability testing programs
- Microbiological testing
- Method development
Technology Integration
Cutting-edge technology platforms and digital systems for enhanced efficiency and quality assurance.
- Digital batch records
- Real-time monitoring
- Automated data collection
- Electronic signatures
Advanced Manufacturing Capabilities
Our manufacturing facilities are designed to the highest standards, incorporating the latest technology and adhering to strict cGMP requirements.
Sterile Manufacturing
ISO Class 7 Cleanrooms
Multiple ISO Class 7 cleanrooms with ISO Class 5 LAF hoods for sterile product manufacturing
Capacity Range
10mL to 1000mL vials, syringes, and bags with flexible batch sizes
Environmental Controls
Continuous temperature, humidity, and pressure monitoring with alarm systems
Non-Sterile Manufacturing
Controlled Environment
Climate-controlled manufacturing areas with HEPA filtration systems
Dosage Forms
Capsules, tablets, topical preparations, and oral solutions
Packaging Lines
Automated packaging with serialization and track & trace capabilities
SGP Care vs. Industry Average
Advanced Manufacturing Equipment
Compounding Systems
- • Automated liquid handling systems
- • High-precision scales and balances
- • Mixing and homogenization equipment
- • pH and conductivity meters
Environmental Control
- • HVAC systems with HEPA filtration
- • Temperature mapping validation
- • Pressure differential monitoring
- • Particle counting systems
Packaging & Labeling
- • Automated labeling systems
- • Serialization capabilities
- • Blister packaging equipment
- • Bottle filling and capping
Comprehensive Laboratory Services
Our analytical and microbiological laboratories provide complete testing capabilities to ensure product quality, safety, and regulatory compliance.
Analytical Laboratory
HPLC/UPLC Systems
Multiple high-performance liquid chromatography systems for potency and purity testing
Spectroscopy
UV-Vis, IR, and NMR spectroscopy for identity and structural analysis
Method Validation
ICH Q2 compliant method development and validation capabilities
Microbiological Testing
Sterility Testing
USP <71> compliant sterility testing for all sterile products
Endotoxin Testing
LAL testing for bacterial endotoxins in injectable products
Environmental Monitoring
Continuous monitoring of manufacturing environments for microbial contamination
Chemical Analysis
- • HPLC/UPLC systems
- • GC-MS instruments
- • Dissolution testing
- • Karl Fischer titration
- • Particle size analysis
Microbiological Testing
- • Sterility testing
- • Bioburden determination
- • Endotoxin testing
- • Antimicrobial effectiveness
- • Environmental monitoring
Stability Testing
- • ICH stability chambers
- • Accelerated studies
- • Real-time stability
- • Photostability testing
- • Container closure integrity
Quality Management Systems
Our comprehensive quality systems ensure consistent product quality and regulatory compliance across all operations.
Quality Infrastructure
Quality Control Release
Comprehensive testing and release procedures for all products
Quality Assurance
Process monitoring and continuous improvement programs
Document Control
Electronic document management with version control
Compliance Framework
cGMP Compliance
Full compliance with FDA 21 CFR Parts 210 & 211 current Good Manufacturing Practice regulations
- • Validated manufacturing processes
- • Equipment qualification protocols
- • Personnel training programs
- • Change control procedures
ISO Certifications
ISO 9001:2015 Quality Management System certification with annual surveillance audits
- • Quality policy and objectives
- • Risk-based thinking
- • Customer satisfaction focus
- • Continuous improvement
Quality Performance Metrics
First-Pass Release Rate
Average Release Time
Regulatory Observations
On-Time Delivery
Frequently Asked Questions About Our Capabilities
Get answers to common questions about our pharmaceutical manufacturing capabilities
Ready to Explore Our Capabilities?
Schedule a facility tour or consultation to see how our advanced capabilities can support your pharmaceutical development and manufacturing needs.
Phone
1-866-565-2225
capabilities@sgpcare.com
Location
SGP Care LLC
777 S. Flagler Dr.
Suite 800 - West Tower
Palm Beach, FL 33401