VALIDATION SERVICES
Our comprehensive range of validation services can be tailor-made to avoid interruption to routine operations. Enhance your team’s confidence to face regulatory audits by having all-time audit-ready reports and documents. We provide not only validation services; our team is available for on-call post-validation technical support and much more. Combined with the expertise of our local and international consultants, our team provides outstanding validation services.
HVAC & CLEANROOM
VALIDATION
Keit Solutions (PVT) Ltd is specialized in HVAC & Cleanroom validation with the latest instrumentation and expert team. We qualify existing and new facilities as per the latest ISO, WHO, EU-GMP & ISPE guidelines. We do installed filter system leakage test, airflow & ACPH (air changes per hour) verification, non-viable particle count test, recovery test, airflow pattern test, air pressure balancing, temperature & humidity verification, light intensity measurement, sound level measurement, validation of laminar air flow units, bio-safety cabinets, isolators, sampling booths, down flow booths and pass boxes and more under HVAC & cleanroom validation.
THERMAL
VALIDATION
Keit solution (Pvt) Ltd is the only service provider in Sri Lanka to pharmaceutical, food, FMCG, healthcare industries & laboratories for thermal validations. We perform qualification and re-qualification of equipment such as dry heat sterilizers (ovens), moist heat sterilizers (autoclaves), sterilization / dehydrogenation tunnels, dehydrogenation ovens, pasteurizers etc. As per the latest ISO, EU-GMP, PDA, HTM & USP guidelines. Also we do sterilization cycle development & validation.
TEMPERATURE & HUMIDITY
MAPPING
The temperature & Humidity of storage areas and chambers are critical factors in ensuring product quality. Qualification and periodic re-qualification of temperature & humidity-controlled areas and equipment should be performed as per WHO guidelines. We perform temperature & humidity mapping of warehouses, stability chambers and temperature mapping of cold rooms, incubators, refrigerators & cold chambers, deep freezers etc.
TRANSPORT
VALIDATION
The inbuilt quality of products & raw materials can be compromised during transportation due to extreme conditions. We at keit provide customized solutions to manufacturers, importers & distributors to validate their transportation processes to achieve regulatory compliance, minimize rejections & maintain product quality. We have Electronic data loggers with, 21-CFR and WHO compliant. Also, we provide NIST traceable calibration certificates for all data loggers used for mapping. We do validation and route profiling of all types of transport channels, Fully compliant documentation, including protocols, reports and summary reports, can be used for any international regulatory audit, Technical support for the identification of worst-case scenarios, Simulation of door opening and temperature control failures/ power failures.
COMPUTER SOFTWARE
ASSUARANCE
In the era of industry revolution 4.0, almost all manufacturing & testing processes are controlled by computerized systems. These systems should comply with 21 CFR part 11, EU Annex 11 & ISPE guidelines. Assurance of the compliance of these systems is essential in exporting pharmaceutical products to regulated markets.
We at keit, validate PLC, SCADA, HMI, MMI & computerized systems, building management systems (BMS) & environment control systems, LIMS & QMS, analytical instrument software and COTS software.
PHARMA & MEDIACAL
GAS TESTING
Quality of pharmaceutical & medical gases is critical as they come into direct contact with the product, sample or patient. As per ISO guidelines, purity, moisture, oil, particulate matter & dew point should be periodically tested.
All Process Gasses | Compressed Air | Medical Air | Nitrogen Gas | Oxygen Gas |
|---|---|---|---|---|
Viable Particle Counts | O₂ test | O₂ test | SO₂ test | Purity test |
Non-Viable Particle Content | SO₂ test | SO₂ test | NOₓ test | CO test |
NOₓ test | NOₓ test | Oil Mist test | Water test | |
Oil Mist test | Oil Mist test | CO test | CO₂ test | |
CO test | CO test | Water test | ||
Water test | Water test | CO₂ test | ||
CO₂ test | CO₂ test | Dew Point test | ||
Dew Point test | Dew Point test | O₂ test | ||
O₂ test | Purity test |
MAINTENANCE
SERVICES
We undertake preventive maintenance schedules of equipment where in-house expertise is not available. Our on-call team of technicians and engineers, who are well-trained in the industry, has all the capabilities to provide effective, high-quality services. Furthermore, we provide scheduled annual maintenance services for specific equipment with a defined number of visits and services to ensure consistent performance of critical equipment. Have peace of mind; leave the rest to us.
