QC Lab Setup Services
At Syshorizon, a team works together for you to shape your dreams into creating a world class lab. So if you are a lab manager, facilities manager, Engineer or contractor who is planning, budgeting, or setting up a new lab or expanding existing facilities, we can help with tailored solutions that meet your specific requirements.
We can help coordinate the procurement, delivery, and installation of a fully Operational laboratory. You gain access to a staff of experts experienced in new lab setup, as well as sourcing for the majority of your equipment and Instrumentation needs.
We do not stop at this but also continue with providing trained staff and providing consultancy in creating LIMS laboratory information and Management systems and ISO 17025 systems
Analytical Method Development & Validation Services
Analytical Method Development has gained a lot of importance because of its role in Analytical Instrumentation. With advantages like at most precision, accuracy & reduced time of analysis, drug development & food analysis .It ensures a cost effective solution to meet specific challenges of Process Development & Method Validation .Today's Pharmaceutical industry, complies with a wide range of standards published in pharmacopeia including IP, BP, USP. Spectro supports its clients with their need for method development & validation as per their specifications for reduction of time, cost along with catering to their need for accurate & precise results. Spectro has a team of highly skilled analysts for Method Development. Our team takes care of all your needs for Method Validation as well. Spectro Service for Method Development & Validation includes analysis of Assay, Stability, Purity, Degradation studies, Formulation development, Characterization, Process validation, Remedial validation, Method transfer, Comparative studies.
Our Scope of Activities for Analytical Method Development Involve
- Discussions with client
- Planning the method development & validation policy as per requirement
- For routine analysis, "QC Plan" will be developed
- Review by QA & data submission to QC Department
- Data Compilation
Cleanroom Validation Services
Our primary cleanroom test battery includes :
- Airflow volume/velocity readings – ensures both unidirectional and non-unidirectional flow areas are properly balanced and unidirectional zones are maintaining proper air patterns
- Room air exchange rate [RAER] – confirms a proper ventilation rate is being achieved
- Room differential pressure testing – verifies room differential pressures meet requirements
- HEPA filter testing – documents leakage or defects and ensures HEPA filters for clean rooms provide required filtration
- Non-viable particle counting – conducted per ISO 14644 or EU Annex 1, reports the amount of airborne particulate of a specified size in the clean zone
- Temperature/relative humidity measurement – confirms whether HVAC controls are functioning properly and uniformly
Optional tests include:
- Air balancing – adjusts airflow in the air handling systems to achieve design airflow, room air exchange rates, and pressure cascade
- Airflow visualization studies – qualitatively verifies airflow direction using a source of visible fog (TSS has several fog options including carbon dioxide, glycol, and liquid nitrogen)
- Viable environmental monitoring [EM] – performed on both air and surfaces to determine if any bacterial and fungal contamination is present
- Compressed air and gas testing – ensures compressed air and gas systems meet the requirements of the controlled environment, testing includes: non-viable and viable particulate, total hydrocarbon (oil), and dew point determination
- Lighting, vibration, and sound tests – performed to design specifications to ensure worker comfort
- Room recovery testing – performed to determine whether an area is capable of returning to a specified cleanliness level after non-routine exposure events