Built on Precision. Powered by Standards.
At Shivoham Pharma Machines LLP, quality is not just a department — it’s the core principle that drives everything we do. From design to dispatch, every stage of our manufacturing process is governed by global pharmaceutical regulatory norms and stringent internal quality systems. Our goal is to consistently deliver machinery that not only meets but exceeds the expectations of regulated markets worldwide.
Commitment to Excellence
We follow a zero-compromise policy when it comes to product safety, sterility, and performance. Our machines are designed to meet the strictest norms laid down by:
- cGMP (Current Good Manufacturing Practices)
- WHO-GMP (World Health Organization – GMP Guidelines)
- US FDA Compliance (as per 21 CFR Part 11 where applicable)
- ISO-9001 Based Internal Quality Systems
Our team of experienced engineers and QA professionals work together to ensure every product passes through multiple levels of inspection, documentation, and testing before it reaches the customer.
Quality Control Measures
We follow structured quality control protocols at every stage of production:
Incoming Raw Material Inspection
- Verified with Mill Test Certificates (MTCs)
- Checked for surface finish, hardness, composition, and tolerances
In-Process Quality Inspection
- CNC/VMC dimensional checks
- Surface roughness and weld integrity testing
- Fitment trials and sub-assembly validation
Final Machine Testing
- Dry Run with actual vials/ampoules
- Output consistency, vibration levels, sealing integrity
- Electrical safety and PLC/HMI functionality
Documentation
- Complete DQ, IQ, OQ, PQ protocols
- FAT (Factory Acceptance Test) & SAT (Site Acceptance Test) reports
- Calibration certificates and validation support
Compliance Highlights
Our machines are designed with:
- Sterile & Cleanroom-Friendly Materials: (SS 304/316L with mirror/matt finishes)
- Audit-Ready Digital Interfaces: Touchscreen HMI/SCADA with data logging (optional 21 CFR Part 11 compliant)
- Validation Support:Full assistance with DQ/IQ/OQ/PQ documentation as per customer protocols
- Change Control & Traceability: Every part is coded and tracked from raw material to dispatch
Testing Equipment in Our Facility
We are equipped with modern tools for precise measurement and quality validation:
- Digital Vernier Calipers & Micrometers
- Surface Roughness Tester
- Welding Penetration Tester
- PLC Simulator & Signal Testing Unit
- Load Cell Calibration Bench
- Flowmeter & Vacuum Testing Setup
- Torque Tester for capping machines
Client-Centric Quality Approach
Every machine we deliver is customized and tested according to the client’s URS (User Requirement Specification) and country-specific compliance norms. Whether you are regulated by the FDA, TGA, EMA, or local drug authorities, we ensure our systems align with your operational and audit requirements.
Our Promise
When you invest in a Shivoham Pharma machine, you’re not just buying a product — you’re securing a compliant, reliable, and long-term partner for your sterile filling line success. Our unwavering dedication to quality and compliance is what sets us apart in the global pharmaceutical machinery landscape.
