Spectro is a well established and fully equipped analytical testing lab which has expertise in carrying out specialized tests for Pharmaceutical industries. Some of the test facilities we provide include:
X-ray diffraction is a commonly employed key technique used to characterize the composition of Drugs as well as cosmetic and personal care products. XRD for powder analysis finds its application in detection & quantifying crystallographic changes, structural characteristics, polymorphic contamination to have a control & enhance quality of the Active Pharma Ingredients (API), raw materials and finished products as well. XRD is also used for solid-state drug analysis, whose results can then be made useful in the process of drug development, process control, testing and production also. Spectro provides a wide range of testing services for Pharmaceutical & Cosmetics testing using XRD technique.
SEM for Powders
Scanning Electron Microscopy is used for qualitative as well as quantitative analysis of Drugs for obtaining information about the shape and surface structure of the material which is a very essential prerequisite in order to develop and maintain the industrial Good Manufacturing Practices (GMP) requirements. Moreover, SEM is a vital tool to characterize nanoscale & sub-micron particles and surface characterization, shelf life studies, evaluating the Flow, compaction, dissolution properties, drug bioavailability, etc. During the process development of initial validation and interpretation of results, a high-resolution imaging with analysis capabilities of an electron microscope is required. Scanning Electron Microscopy also plays an important role in drug excipient homogeneity analysis to conduct study of the raw materials which are used in the formulation & their composition and analyzing the active ingredients distribution within the excipient matrix in the final product. Various cosmetic products which are in powder form are also evaluated using SEM technique for analyzing shape, morphology, shelf life, surface characterization & many other elemental information of the final product.
Spectro Instrumentation Facility for Testing of Cosmetics & Pharmaceuticals
Total Organic Carbon (TOC) analyzer
Atomic Absorption Spectrophotometer
Compressed Air Monitoring Kits
Some of our Services for Cleanrooms Include:
Particle Count Monitoring
Bacterial count in air under specific operating conditions
HEPA Filter Integrity Test
HEPA Filter Leak test
Air Velocity Measurement
Compressed Air Test
Sound level test
Total Organic Carbon (TOC)
Air Flow Pattern
Light intensity test
Determining Microbiological Exposure on clothes and body of the personnel
OT Room Validation in Hospitals as per NABH Guidelines
AMC Services of OT Rooms
Fume exhaust systems- Testing & Validation
Compressed Air Testing as per USP and GA Guidelines
Microbial sampling and enumerating the surfaces.
Thermal Mapping of Storage Rooms
In pharmaceutical industries, cold rooms, freezer rooms, incubators, sample rooms, refrigerators, raw material storage areas, stability chambers, packing areas and other temperature-controlled stores are required to be regularly validated for temperature and humidity. It also includes the laboratories, loading/ unloading areas and the areas where temperature sensitive products are kept or even held when in transit. The objective of conducting temperature mapping study is to control and document the temperature variation within a specified storage area and locate the cold and hot spots. Thermal mapping is essential to identify the zones where remedial actions are to be taken, for instance, either by changing the air distribution to eliminate the cold and hot spots or retro-fitting new air distribution equipment to lower the temperature.
Subsequent temperature and humidity mapping exercises are not a single time job, it is to be performed periodically, say every three years to keep a check on compliance. It is important to carry out thermal mapping whenever a significant modification is done in the storage area or room or in case there is any modification done in the equipment. All these mapping exercises need to be completely documented to demonstrate the compliance to management as well as regulatory bodies. The allowed temperature range may vary from -25°C to -10°C or 15°C to 25°C.
Thermal mapping requires an adequate number of Electronic Data Logging Monitors that makes sure that the temperature distribution within the specified space is characterized sufficiently. Along with the data logger units, computer and software is required to store and check the data. Based on the data and analysis reports, appropriate recommendations are made for any remedial actions required to overcome the issues identified during the exercise.
Thermal Validation of Equipment
Autoclave is an essential tool used for sterilizing the surgical dressing, glassware, biohazardous waste; several types of microbiological media, etc. to follow the FDA, WHO & EU guidelines. This makes thermal mapping of these type of equipment, an essential activity in pharma and healthcare industries.
Autoclaving is the most significant means of sterilization, all the autoclaves are mandatory to go through GMP process of validation or qualification.
Calibration of Equipment
Calibration is an important component to make sure the validity of qualification, it also include validation of computer system. Calibration is a vital activity to be performed in order to build a perfect Quality System Management with a team of qualified experts. Calibration should be carried out with the help of appropriate and proficient instrument through an accredited laboratory. Spectro is a well-known name in providing services for calibration. We are accredited as per ISO 17025 for Calibration in the field of Mechanical, Thermal, Electro-technical and Flow calibration.
Performing calibration of an instrument is a necessity to be performed at regular intervals because the instruments tend to deviate being under stringent operating conditions, harsh environmental conditions and mechanical shocks as well. The objective of calibrating an instrument is to determine its accuracy and adjusting its precision which involves obtaining a reading and measuring the variation between the standard values and the obtained values.
In pharma industries, temperature reading has a great impact on each step of processing. Thus temperature calibration is conducted very frequently and under the controlled environment. Some of the temperature measuring instrument that is required to be calibrated periodically includes: