Pharma and Biotech Services

Our Main services:

  • Facility & Utility Projects like (Boiler,Chiller,Cooling Tower ,Hot water system ,Solar panel Projects,Process Chiller system).
  • Shutdown activity support works.
  • All Fabrication works. like SS tables ,chairs ,tanks,all SS works & MS pipe line works
  • HVAC projects like (AHU ,EAU,VAU) and Ducting work and BMS & EMS as well
  • Floor Revamping /Epoxy works.
  • Clean Room Garments Supply.
  • Pipe line modification and Pipe line installation works.
  • Technical / Non Technical manpower supply services (Housekeeping ,Production support ,QC support ,packing support Manpower).
  • Cleanroom Garments/ Gowning.
  • CSV & Automation support service.
  • Green field and Brownfield projects.
  • Boiler ,chiller ,CT (Cooling Tower) up-gradation projects.
  • we provide all the Consumable / spare parts for all the equipment's.
  • Autoclave PLC upgradation works.
  • Specialized on PLC projects.
  • clean room panel works
  • Aluminium partitions & cladding building Elivation works.

Utility projects in the pharmaceutical industry are crucial for ensuring that facilities operate efficiently and comply with stringent regulatory standards. Here are key aspects and types of utility projects typically involved:

1. Water Systems

Purified Water Systems: Design and installation of water treatment systems to produce purified water for manufacturing.

WFI (Water for Injection) Systems: Implementing systems that meet the quality requirements for water used in injectable formulations.

2. HVAC Systems

Controlled Environment: Designing HVAC systems that provide appropriate temperature, humidity, and air quality in production and storage areas.

Cleanroom Design: Creating and maintaining cleanrooms that meet ISO standards for aseptic processes.

3. Steam Systems

Steam Generation: Installation of boilers and steam distribution systems for sterilization and process heating.

Condensate Return Systems: Designing systems to optimize energy efficiency and water usage.

4. Compressed Air Systems

Quality Compressed Air: Implementing systems that ensure the purity and reliability of compressed air used in production.

Energy Efficiency Upgrades: Upgrading existing systems to improve efficiency and reduce operational costs.

5. Electrical Systems

Power Distribution: Designing electrical systems for reliable power supply, including backup systems like generators.

Lighting Design: Implementing energy-efficient lighting systems compliant with regulatory requirements.

6. Waste Management Systems

Effluent Treatment Plants (ETP): Designing systems for treating wastewater generated during pharmaceutical manufacturing.

Solid Waste Management: Establishing protocols and systems for the safe disposal of hazardous waste.

7. Automation and Control Systems

Building Management Systems (BMS): Implementing automation for monitoring and controlling utilities.

Process Control Systems: Enhancing operational efficiency through automation of critical utility processes.

8. Energy Management

Energy Audits: Conducting audits to identify energy-saving opportunities.

Renewable Energy Solutions: Exploring solar, wind, or other renewable sources to supplement energy needs. Conclusion

Utility projects in pharma not only enhance operational efficiency but also ensure compliance with safety and quality standards. Careful planning, design, and implementation are essential for the success of these projects.

COMPUTER SYSTEM VALIDATION SERVICES

Life Science services need to ensure their computer systems constantly meet the standard requirements of complex software protocol. The process involves the provisions for documented evidences that the current computer system is compliant with complex laboratory requirements. The validation process involves the adoption of rigid verification methods to ensure the system can handle the requirements of specialized niche scientific software protocols. SPCS is capable of handling the entire range of operations, whether you have a simple PLC system or a complex ERP application. The validatory process confirms effectively with documented directives that each installed application in the laboratory computer systems fulfills its intended purpose. We are competent at handling specialized software system requirements in pharmaceuticals, biotechnology, and medical device manufacturing protocols. The validation process guarantees the reliability, availability, and integrity of the business data in Life Science systems, establishing a proper workflow with intended results in each production cycle.

  • Programmable Logic control.
  • Control system and software.
  • BMS (Building management system).
  • SCADA (supervisory Control and data acquisition system).
  • Manufacturing Execution System.
  • Analytical Software.
  • Lab Equipment software validation.
  • SAP/ERP Software validation.
  • Laboratory Information Management system Validation.
  • Excel sheet/Excel sheet development and validation(as per 21 CFR Part 11).
  • Any type Customized software.

Computer system validation activity is done as per GAMP 5 and 21 CFR11 or as per standard specified by Life Sciences from time to time.


COMPUTER SYSTEM VALIDATION DELIVERABLES

  • Validation Master plan.
  • System risk assessment report/Failure Mode Effect Analysis.
  • User requirements specification.
  • GAP Assessment.
  • Gxp Assessment.
  • System configuration specification.
  • Function Design Specification.
  • Test plan.
  • Installation Qualification (IQ) testing and results.
  • Operation Qualification (OQ) testing and results.
  • Performance Qualification (PQ) testing and results.
  • Optional) Assessment for compliance with regulations pertaining to electronic records and signatures (e.g., 21 CFR Part 11).
  • Validation traceability matrix.
  • Quality assurance review.
  • Validation summary report.
  • Review of Standard Operating Procedures (SOPs).
  • Technical support.

Automation and Instrumentation

1. Turnkey Electrical Systems

The technical specialists attend to the diverse requirements of establishing an electrical system in the Turnkey protocol. We handle the full range of services commencing with project implementation, strategic consulting, and the final production. The intermediary procedures such as site acceptance, design, engineering, followed by installation receives our full attention. We also attend to commissioning and procurement requirements according to industry standards.
2. Complete Electrical Engineering Services

The engineering services provided by SPCS include power studies and implementation of power distribution services as according to the unique requirements of a process. We also handle automation system design, drives systems, and HMI systems within our Electrical Engineering repertoire.
3. On- site installation

Our competent engineers can effectively handle on site electrical systems installation of advanced machines along with the control wiring or power cabling.
4. System upgrades in automation protocols

Electrical engineering requirements may require the progressive migration from legacy systems to the state of the art control systems in the process. We have diverse experience at interpreting the upgrade requirements at tandem with the advanced control systems such as ABB, Allen Bradley, and Siemens S7/PCS 7. Contact us with your unique queries to receive prompt replies. We evaluate your unique requirements in suggesting the best solutions meeting the demands of enhanced productivity.
5. Energy management

Adequate energy management is vital for the smooth and cost effective operations of your processes. We ensure smooth transition and distribution of the energy load in your unit. Our energy consumption monitoring services include lighting, electrical power monitoring, water usage, steam, compressed air units, chillers, and boiler units.
6. Available at emergencies

Despite best efforts, electrical systems are vulnerable to breakdowns and other major issues. Our competent staff is available 24/7 with the guarantee of complete assistance in maintaining the constant uptime of your equipment’s and process circuits.

COMPANY REFERENCE FOR CSV WORK AND AUTOMATION

  • STADA-VIETNAM (CSV, BMS AUTOMATION, MACHINE AUTOMATION).
  • PYMEPHARCO-VIETNAM (CSV, BMS AUTOMATION, MACHINE AUTOMATION).
  • MENOVO-CHINA (CSV).
  • AMNEAL-INDIA (CSV).
  • INTAS PHARMA-INDIA (CSV).
  • AKUMS DRUGS- INDIA (CSV, MACHINE AUTOMATION).
  • ZYDUS-INDIA (CSV).
  • PIRAMAL HEALTHCARE-INDIA (CSV).
  • HOSPIRA-INDIA(CSV).
  • TORRENT-INDIA(CSV).
  • SUN PHARMA-INDIA (CSV).
  • INDOCO-INDIA (CSV).
  • CIPLA-INDIA (CSV).
  • APOTEX-INDIA(CSV, MACHINE AUTOMATION).
  • STRIDES ARCOLABS-INDIA (CSV).
  • AUROBINDO-INDIA (CSV).
  • SHILPA MEDICARE-INDIA (CSV).
  • HETERO DRUGS-INDIA (CSV).
  • CADILA HEALTHCARE (CSV , MACHINE AUTOMATION).
  • WYETH-INDIA (CSV).
  • DR REDDY’S LABORATORY-(CSV).
  • AIA ENGINEERING-INDIA ( PLANT AUTOMATION).
  • FORACE POLYMER-INDIA (REACTOR AUTOMATION).
  • KNAPP LOGISTICS- USA (MACHINE AUTOMATION).
  • LUBING-USA (MACHINE AUTOMATION).

OTHER SERVICES

  • Prepare Complete Qualification Document of the HVAC System i.e. Design Qualification , Installation Qualification ,Operation Qualification & Performance Qualification.
  • Performed operational Qualification Study, Supervised the critical job of HEPA Filter Installation.
  • Perform Validation of HVAC System which includes.
    1. Air Velocity Measurement.
    2. Air Balancing.
    3. Pressure Balancing.
    4. Temperature Mapping.
    5. HEPA Filter Integrity Test ( with PAO Solution).
    6. Non Viable Particle Count Study.
    7. Recovery Time Study.
    8. Air Flow Pattern Test.
  • Perform Validation of Compressed Air Distribution System.
  • Perform Validation of Nitrogen Distribution System.
  • Perform Validation of Pure Steam System.
  • Temperature & Rh mapping of Clean Room.
  • Temperature mapping of Autoclave, DHS, Tunnel,Incubators etc.
  • Consultation on Microbiology laboaratory facility, procedures and method validations inline to cGMP.
  • Track wise Develop :00S,OOTrends,OOL,Laboratory Incident management.

COMPLIANCE SERVICES

  • Computer System Validation.
  • Laboratory Information Management System (LIMS) validation.
  • Custom Database and Spreadsheet Development (21 CFR part 11) and validation.
  • SAP/Customized ERP system Validation.
  • HPLC, GC, SAS software, Chem. Station, WinNonlin, Volunteer Database Software, LCMS and other Chromatography equipment software validation, including configuration and validation of network data systems.
  • Development of requirement specifications, documentation, traceability matrices and other GAMP documentation.
  • System Risk Assessments.
  • Support for preparation of URS and FS.
  • Design Specification.
  • GAP Analysis.
  • 21CFR Part 11 compliance assessment, Electronic Records and Electronic Signature.
  • IT Infrastructure assessments and validation.
  • IQ/OQ/PQ validation protocol preparation and execution.
  • IT SOP preparation support.
  • Reports and Corrective Actions recommendations.
  • EU and USFDA Audit Support.