Within our range of services, one of the most important and complete are qualification services oriented to pharmaceutical and sanitary industry. The purpose of this service is to check that an equipment or environment behaves appropriately according to the regulations which apply. For this and in different stages of qualification (IQ, OQ, PQ) the installation and performance is compliance regulations.
Different types of qualification Vality offers in its portfolio of services are:
We developed qualifications and environmental control of HVAC systems in sterile and surgical areas and in air equipments. Our aim is to guarantee the quality of the air to protect both the production process and the welfare of your employees. To do so, we follow and respect the present legislation (Annex 1 GMP7ISO 14644). We count on the best professionals for the drafting of protocols and their execution.
Either before or after the qualification is done, we can run preventive maintenance in your facilities or equipments to assure their right performance.
Different types of qualification Vality offers in its portfolio of services are:
Qualification in surgical areas and clean room areas.
Qualification of cabinets and air equipments:
- Laminar flow cabinet
- Biological safety cabinet
- Gas-venting air flow cabinet
Qualification of controlled environment monitoring systems
Qualification in protection areas p2, p3, p4.
Qualification of units of impulsion and extraction of air in conditioners and insulators, laminar flow modules and protective and heavy cabins.
We can qualify systems for the generation of compressed gases and bottled gases (Compressed air (AC), Nitrogen (N2) and rest of pure compressed gases).
We offer the possibility to complement the qualification of your equipment and air installations with a biological qualification. This last step will measured the microbiological load proving this way that we accomplished the regulations in force.
The main aim of a thermal qualification is to measure the temperatures conditions of a process, installation or equipment maintain over a period of time.. It also gives extra information given by the register system of the equipment and allows the technicians to know better the real conditions of the process.
In a qualification process we also measure pressure, humidity and gases (CO2, O2, N2, etc.), depending on the equipment that has been qualified.
Types of thermal qualification:
Sterilization equipment and processes by physical methods (autoclaves, steam generation and distribution, furnaces, sterilization tunnels, freeze dryers, SIP, reactors, etc.) or chemicals, (by immersion, gas, hydrogen peroxide vapor, plasma and oxide of ethylene). In addition to the temperature, during the qualification we check critical parameters that intervene such as pressure, vacuum, relative humidity and perform qualifications to determine the microbiological load (PQ) with biological indicators.
Systems of liquids generator in processes according with the FDA (Guide to Inspections of High Purity Water Systems). CGMP, solutions, effluents, running water (potable or not) purified water and WFI.
Equipments and installations of controlled temperatures: Climate chambers, refrigerators, freezers and ultra-freezers, cold stores, vacuum stoves, ovens and muffles, incubators, hot room etc.
Freeze dryers technique (solution, suspension, animal and vegetable tissue, food products, etc.) according with GMP.
Storage, transfer and transport processes according to – GDP (Good Distribution Practice) and the NCF Guide Annex 15, capable of ensuring the storage and transport conditions of the products, for quality assurance and maintenance of the cold chain
The qualification of production equipment with GMP/NCF in each one of the qualification phases IQ, OQ and PQ, are fundamental. Why? Because it allows us to have a better knowledge of its condition and efficiency, improving the viability and productivity in production equipments (packaging machine, fluid beds, capping…) and analytical equipments (HPLC, spectometer etc.). Besides, the improvement of the quality control processes allow us to know better our products and raw materials used, optimizing the analysis times.
Qualification: test runned to prove if an equipment is working properly or produces the results expected. The term “validation” is sometimes used as qualification.
Vality Pharma Consulting has the best technological and human means, to commit any type of qualification in any of its phases and reaching all the standards of quality fixed in out PNT´s.
URS reports
Risk management documents
FAT and SAT tests/span>
Final Qualification Report
URS document writing
Protocols (IQ, OQ y PQ). The most usual are the following:
- Particle counting.
- Integrity test in filters.
- Differential pressure and pressure loss in filters.
- Determination of air flow.
- Recovery test.
- Determination of temperature and relative humidity.
- Determinatio of the ligth level.
- Determination of the noise level.
- Display of air flow.
- Speed and uniformity of air.
- Test in steam.
- Mappings with thermocouple probes.
- Mapping with wireless probes.
- Parallelism test.
- Conservation and handling in sampling plates in microbiological control.
- Tightness test.
- Counting of particles in service lines.
- Microbiological control in service.
- Microbiological control in clean areas.
- Manipulation of filters with risk residues.
- Verification of the control operation of the equipment.
- Freeze dryers test.
- Temperature distribution test with thermocouples.
- Determination of oil in service lines.
- Determination of the dew point in service lines.
- Formaldehyde sterilizers tests
- Ethylene oxide sterilizers tests.
- Duct leakage test.
- Determination of ultraviolet light in installations and equipment.
- Determination of carbon saturation for xylene and formalin in extraction cabins.
- Saturation test.
- Temperature penetration test with thermocouples and / or indicators.
- Decontamination with formaldehyde of biological safety cabinets.
- Containment by smoke tube.
- Filters replacement
The logistics sector is growing-fast sector. Some companies required a great logistic system for their products movements as it is the key in order to warrantee optimal conditions at the warehouse and during the transportation of their products, especially the pharmaceutical.
Vality counts on qualified technicians and state-of-the-art instruments to carry out all the necessary processes to warranty the conservation and distribution of products without affecting its properties.
To do so, the environmental conditions are controlled during transportation (land, sea or air) in different packaging but also at the warehouse and the company facilities.
For this security to be a reality we develop the following services:
Analysis and location of control probes.
Calibration of means of transport and registration probes en route.
Validation of transport routes
Thermal mappings summer/winter, vacuum/load, determination of cold/hot points.
Validation of packaging for refrigerated transport.
