Calibration:

UMED is an Independent Calibration Facility setup providing services for the following parameters at its state of the laboratories which is equipped with calibration standards from world renowned brands like Fluke, WIKA.

• Thermal Validation
• Sterilisers / Processing Equipments
• QA/QC Equipments
• Ware House Mapping
• Cold Chain Management
• Hospital Room Monitoring

HVAC Validation

Cleanroom Validation/HVAC Validation is performed for a variety of reasons. To ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets to ensure that the facility, equipment, and Environment meet defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system to meet defined standards. UMED PHARMA performs the HVAC validations as per ISO 14644- 1, 2,3, EU GMP/EC GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) guidelines for all room classifications

Air flow Test & ACPH Calculations

We conduct Air Velocity Measurement to determine the average filter face velocity and uniformity, and the average room airflow velocity and uniformity within a clean room. These test can be conduct by using anemometer or Capture wood.
Installed Filter System Leakage Test (using PAO)
We conduct complete HEPA/ULPA filter integrity testing services. These are offered for both the Pharmaceutical, Food, biotech and other Microelectronics industries. All filter integrity tests performed as per ISO 14644.

Non-Viable Particle Count Test

We are UMED a reputed name in offering clean room validation services. Our Particle Count Test provides complete airborne particle count cleanliness classification. The test identifies particle count on basis of As-Built, At-Rest, or Operational as per ISO 14644 , EU GMP.

Recovery Test

We execute recovery tests for clients across Industries. These tests demonstrate the ability of the clean room to remove particulate by purging the area with filtered air. It also testifies if the room can change from a “dirty” to “clean” state within the specified time. We ensure that client’s clean room facility is performing properly and accurately.

Air Flow Pattern Test (Using Water Fogger)

We offer Airflow Visualization Test as a part of the validation process. Visualization is carried out by using water fogger and taking Video Graph. The purpose of the airflow visualization test is to show the actual airflow pattern throughout the unidirectional clean room.

Containment Test

We conduct Containment Tests for client’s clean room facility. The test is carried to demonstrate that airborne contamination does not enter from a higher pressure area adjacent to the clean room by means of leaks in the construction materials.
Temperature & RH Measurement
We conduct validation tests that include Temperature and Humidity Measurements for Production, Warehouse, to ensure that the clean room’s HVAC system maintains the specified levels of temperature and humidity required for occupant comfort. The second level or the comprehensive level test identified that the clean room HVAC systems needs to maintain the specified levels of temperature and humidity required for both occupant comfort and process temperature control.

Light Intensity Measurement

The purpose of the lighting level tests is to verify that the installed light levels and uniformity meet the specified requirements. We make use of modern testing instruments for assessment of lighting lux levels and intensity.

Sound Level Measurement

We perform noise level test that measure the sound pressure. The measurements will vary based on the occupancy state-of-the-art clean room. The purpose may vary but the procedures of testing are identical.

PLC / CSV Validation

Umed is a leader in regulatory compliance & validation consulting & services. Umed also pioneer for Regulatory compliance Services in India & the largest company that provides software Categorization & other GAMP based validation consulting in India & abroad.
We have the knowledge and experience to help the customer’s access and define their compliance and validation requirements. Our portfolio of services encompasses the entire product life cycle and Includes GAMP Compliances Services, Software Testing & Validation and projects requiring the integrated services of both these services.Validation of ERP & Manufacturing Execution Systems(MES)

• Validation of LIMS(Laboratory Information & Management Systems)
• Validation for other manufacturing automation systems such as Building Management Systems, Track & Trace Systems
• Validation of PLC & DCS based control systems as per Gamp & 21 part 11
• Comprehensive GAP & RISK Analysis for PLC & DCS based control systems as per GAMP WE perform all the CSVMP for regulatory body. Validate DCS/SCADA/PLC based Systems Process Equipment validation
• Validate Laboratory Equipment Software, IT Systems, as per GAMP-5

Pharmaceutical Gases & Pure Stream Validation

Compressed Air

The Compressed air that comes in direct contact with Pharmaceutical Products is vital to assuring the Quality and safety of those products as per ISO 8573-1, EP, BP, and USP the following parameters need to be performed once in a year.

Compressed Air Test Parameters

• Appearance
• Solubility
• Oil mist
• Identification
• Dew Point
• Microbial counts
• Hydrocarbons
• Sulfur Dioxide
• NO2
• Moisture content
• Carbon Dioxide Concentration
• Carbon monoxide concentration
• Dust Particles monitoring [NVPC]
• Suspended Particulate Matter
• Oxygen Content

Nitrogen

Nitrogen Gas is a Critical Component in the Production of Pharmaceutical Industry and effects on the Quality of the end Product. Therefore, it should be monitored and ensure that the desired quality of the nitrogen air is used in Production and need to be monitored once in a year as per ISO 8573-1, EP, BP, and USP the following parameters need to be performed once in a year.

• Nitrogen Test Parameters
• Description / Characters
• Identification
• Oxygen Content
• Moisture content
• Microbial counts
• Oil mist
• NO+NO2
• Solubility
• Dew Point
• Sulfur Dioxide
• Suspended Particulate Matter
• Nitrogen Purity Test by GC
• Dust Particles monitoring [NVPC]
• Carbon Dioxide Concentration

Breathing Air

Breathing Air Validation – The Quality of Breathing air is important to ensure that the respiration System will function properly and reliable, Clean Natural Air is an odorless, colorless Gas mixture, Air contains three major elements makeup about 99.97% of Dry Air: Nitrogen [N2] at 78.09%, Oxygen [O2] at 20.95%, Argon [AR] at 0.93% an important minor component of Natural air is Carbon Dioxide [CO2] at 0.03% [300ppm].

Breathing Air Test Parameters

• NO+NO2
• Sulfur Dioxide
• Oxygen Content
• CO2 Concentration
• CO concentration

Pure Steam Quality Testing

Steam Quality test to Qualify Plant / Utility / Clean / Pure steam generators, Steam Distribution systems and steam supplies to Autoclaves in accordance with cGMP, HTM2010, EN285, DIN 58950, ISO 14937:2000, ASTM ST79, ISPE Baseline guide for steam and water and PDA Technical Report No.1 & 48.

Steam Quality Test Parameters

• Non condensable gases [Inert gases]
• Dryness Value
• Super heat Testing

Filter Integrity Test For Gas Filters [Compressed Air & Nitrogen]

Hydrophobic sterilizing grade Gas cartridge Filters shall be used for gases filtration, like Compressed Air, Nitrogen and Other Process gasses which directly contacts with Pharmaceutical Products that are vital to assuring the Quality and safety of those products as per PDA Technical report 6 the following parameters need to be perform once in six months or a year / as per the Requirement

Filter Integrity Test Methods

Water Intrusion Test

Is widely utilized in Bio /Pharmaceutical Manufacturing and Research Laboratories to perform inline integrity testing of Sterilizing grade gas filters with hydrophobic membranes. The Palltronic Flow star IV Instrument is specially designed and validated to perform this very sensitive test.

Bubble Point

The Palltronic Flow star IV integrity test instrument can determine the Bubble Point of a filter. The gas flow rate is measured at increasing pressure steps, and the Bubble Point is the transition of diffusive gas flow through wetted filter pores to bulk gas flow through de-wetted filter pores.

Forward flow Test

The Forward flow is the Filter Integrity test that is most common in Bio / Pharmaceutical manufacturing. All major filters supplier recommended the forward flow test as the method of choice for integrity testing of filter cartridge or capsule assemblies. The Palltronic Flow star IV instrument performs the forward flow test quickly and with extreme accuracy. The volume dosed flow meter can perform a forward flow test in a range of 0.1 to 1000 mL / min within minutes and with an accuracy of 0.1 mL / min or 3%.

Equipment / Facility Qualification

Qualification / Validation shall be used as a tool for providing a high degree of assurance that a specific system, process or facility will consistently produce a product meeting its predetermined specification and quality attributes.

All the qualification / validation activities performed by UMED shall be based on scientific rationale and risk based approach.

All GxP requirements shall be considered during designing of the facility and subsequently qualified before put into operational use. Equipment related to process, laboratory and supporting utilities shall be qualified before use.

Typically, Qualification consists of:

• User Requirement specification (URS)
• System Level Impact assessment (SLIA)
• Vendor Quality Assurance plan (VQAP)
• Design Qualification (DQ) (Functional and Design Specification)
• Quality Risk Assessment (QRA)
• Factory acceptance test (FAT)
• Site acceptance test (SAT)
• Component level impact assessment(CLIA)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)