What is Analytical Testing?
Analytical testing is a study or analysis using the proven scientific procedures to ensure that the sample is produced by following GMP. In order to ensure that GMP is followed the analytical testing laboratory has to follow all the norms of GLP.
In Analytical testing procedure samples are thoroughly analyzed for identification, purity, contamination and stability of the composition. In various manufacturing sectors. It is used to perform reverse engineering, failure analysis and contamination analysis.
Thus, in depth knowledge of analytical techniques, procedure and how to apply it on samples to identify impurities is important. To do so, it requires highly experienced professionals and high precision instruments.
Analytical tests we perform
Humongous Labs (OPC) Pvt. Ltd. has adequate human resources and high precision instruments like- .
- Physical characterization,
- Physicochemical methods,
- Surface analysis techniques
- Chromatography
- Liquid
- Gas
- Spectroscopy
- UV
- FTIR
- Atomic Absorption
- Particle size techniques,
- Microscopy
- Visual
And other chemical testing and analysis procedures to cater testing needs according to your business requirements of analytical testing needs.
Why Humongous Labs?
Humongous Labs (OPC) Pvt. Ltd. has taken scope to perform chemical composition analysis, elemental analysis, molecular structure elucidation, contamination detection, materials analysis from accreditation authorities.
Pharmaceutical Products Testing
In this process, analytical testing procedures are performed on raw and finished products for identification, purity, contamination and stability of the composition. To do so, we applied any one of the following method as per the references like IP, BP, USP, EP, JP or Manufacturer’s in-house methods:
- Physical characterization,
- Physicochemical methods,
- Surface analysis techniques
- Chromatography
- Liquid
- Gas
- Spectroscopy
- UV
- FTIR
- Atomic Absorption
- Particle size techniques,
- Microscopy
- Visual
Humongous Labs (OPC) Pvt Ltd. has state of the art chemical, instrumentation and microbiology laboratories to carry out analytical testing of raw and finished pharmaceutical products. Each section of the laboratory is equipped with modern edge instruments which help in speedier analysis of the samples.
Using the above facilities our experienced staff follows scientifically proven methods to perform all the analytical tests following the GLP practices to prove that the sample is produced in accordance to the GMP practices and conforms to the guidelines of the various references like IP/BP/ USP etc. As well as end product adheres to the guidelines of the various regulatory and governing bodies
Humongous Labs (OPC) Pvt. Ltd. is equipped with to perform the analytical testing on:
- Capsules
- Tablets
- Syrups and dry syrups
- Suppositories,
- Pessaries
- Eye drops,
- Ointments
- Transdermal patches
- Small volume and large volume parenteral
- Surgical and Sutures
How Humongous Helps?
We can take over the burden of performing the analytical testing of your raw and finished pharmaceutical products. And enable you with the report stating that your product is in accordance with governing bodies guidelines. This helps you in focusing on producing your raw and finished pharmaceutical products according to the GLP guidelines.
Pharmaceutical Method validation
Pharmaceutical industry is research driven and constantly trying to improve their formulations. In this pursuit Humongous Labs (OPC) Pvt. Ltd. will be your trusted partner by sharing the load of method validation. And enables your organization to focus on improving the formulation.
Humongous Labs (OPC) Pvt Ltd with its state of the art facilities, instruments and experienced staff can be proved as a force multiplier for your research and method development team. With our inputs you can improve your formulations and make it conform to the various pharmacopoeial standards like IP, BP, USP etc.
Our reports also enable your organization to get necessary accreditations for the developed method. And you can release your finished pharmaceutical product to market in a short span of time.
Services offered
- Comprehensive analysis of the raw and finished products
- Identification of uncertainties measurements
- Stability analysis
- Method Validation/Verification
- Chemical composition analysis
- Impurity analysis
- Physicochemical analysis
- Microbiological analysis
Pharmaceutical Method Development
In the pharmaceutical world, method development is a continuous process to improve the end product to achieve any one or all like manufacturing time, cost or improve efficiency. An effectiveness of the developed method can only be ensured by constant validation. During the validation process the drug produced by recently developed method undergoes various analytical procedures outlined by the International conference on Harmonization (ICH) namely:
- Identification tests
- Quantitative test on active moiety in the API or finished drug
- Quantitative test for impurity
- Limit tests for control impurity.
To carry out the above mentioned broad category of tests, you are required to have a state of art laboratory with all instruments and knowledgeable human resources. In this constant stead of product evaluation Humongous Labs (OPC) Pvt. Ltd. can be your trust partner and force multiplier with its following capabilities:
- State of art microbiology laboratory
- Well equipped Gas chromatography laboratory
- High end liquid chromatography laboratory
- Modern edge UV and FTIR laboratory
- Physicochemical laboratory
And too operate above equipment we have experienced and highly trained man-power which helps you build your product as per various pharmacopoeias like IP, BP and USP
Similarly, we would also be able to assist you in developing your in-house method or non-pharmacopeia methods and help you certify as per various pharmacopoeias like IP, BP and USP.
Microbiology
Humongous Labs (OPC) Pvt Ltd. has a world class microbiology laboratory with experienced staff to perform microbiological analysis to identify the microbial contamination in the end product whether it is pharmaceutical, food, water and cosmetics.
Microbial contamination testing is mandatory and recommended in any sector which involves manufacturing products which humans are going to consume irrespective of intake type whether it is oral, nasal, external, and injectables. Due to this reason all food, pharmaceutical and cosmetic products have to undergo microbiological contamination testing. To ensure the raw and finished product is free from microbial contamination. And your product is able to comply and be manufactured as per various governing body standards.
Humongous Labs (OPC) Pvt. Ltd. proudly offers its microbiological laboratory and expertise to you. So that you are not worried about it and focus on increasing your production. We offer microbiological services for following categories:
- Drug and Pharmaceutical microbiological analysis
- Food products microbiological analysis
- Cosmetic and personal care products microbiological analysis
- Packaged and unpackaged mineral water microbiological analysis
Drug and Pharmaceutical microbiological analysis
In order to ensure that the produced raw and finished pharmaceutical product is free from any microbial contamination. And safe for consumption for humans irrespective of intake type whether it is oral, nasal, external, and injectables.
Our microbiology laboratory is well equipped and has experienced and expert human resource to carry out following microbiology analytical procedure outlined below:
- Sterility testing
- To ensure that produced raw and finished pharmaceutical product is safe for human consumption we applied following procedures:
- Direct Inoculation
- Membrane filtration
- To ensure that produced raw and finished pharmaceutical product is safe for human consumption we applied following procedures:
- Bacterial Endotoxin Testing
- Our microbiologist has expertise in performing Limulus Amoebocyte Lysate (LAL) test on the produced raw and finished pharmaceutical product to ensure that it is free from endotoxins
- Microbial Limit Test
- Usually, the said test is performed on non-sterile produced raw and finished pharmaceutical products. Specifically, which are produced according to harmonised pharmacopoeia or manufacturer’s in-house method is used to identify the bio-burden of the sample
- Total Bacterial Count:
- In this test, we are equipped to identify the bacterial count in the raw and finished pharmaceutical products which helps in determining the presence of microorganisms in said product. The identification criteria is CFU (colony forming unit) per gram or ml should not be greater than the specified guideline.
- Total Fungal Count:
- Indicates the presence of fungal
- Pathogen detection
- In produced raw and finished pharmaceutical products pathogens may be referred to as infectious agents. Our microbiology laboratory is fully equipped and microbiologist has the expertise in identifying following pathogens:
- Algae
- Bacteria
- Fungi
- Prions
- Viroids
- Viruses
- In produced raw and finished pharmaceutical products pathogens may be referred to as infectious agents. Our microbiology laboratory is fully equipped and microbiologist has the expertise in identifying following pathogens:
- Antimicrobial Efficacy Testing
- Antimicrobial agents are those which can kill microorganisms. In this Antimicrobial Effectiveness test, it is ensured that raw and finished pharmaceutical products have capability to kill microorganisms. Also, its repeated use is safe for humans.
Food products microbiological analysis
Similarly, detection of the microbiological contamination is necessary in food products as well.
Our microbiology laboratory is well equipped and has experienced and expert human resource to carry out following microbiology analytical procedure outlined below:
- Bacterial Endotoxin Testing
- Our microbiologist has expertise in performing Limulus Amoebocyte Lysate (LAL) test on the produced food product to ensure that it is free from endotoxins
- Microbial Limit Test
- Usually, the said test is performed on non-sterile produced food products. Specifically, which are produced according to harmonised pharmacopoeia or manufacturer’s in-house method is used to identify the bio-burden of the sample
- Total Bacterial Count:
- In this test, we are equipped to identify the bacterial count in the food products which helps in determining the presence of microorganisms in said product. The identification criteria is CFU (colony forming unit) per gram or ml should not be greater than the specified guideline.
- Total Fungal Count:
- Indicates the presence of fungal
- Pathogen detection
- In produced food products pathogens may be referred to as infectious agents. Our microbiology laboratory is fully equipped and microbiologist has the expertise in identifying following pathogens:
- Algae
- Bacteria
- Fungi
- Prions
- In produced food products pathogens may be referred to as infectious agents. Our microbiology laboratory is fully equipped and microbiologist has the expertise in identifying following pathogens:
Cosmetic and personal care products microbiological analysis
Our microbiology laboratory is well equipped and has experienced and expert human resource to carry out following microbiology analytical procedure outlined on Cosmetic and personal care products:
- Microbial Limit Test
- Usually, the said test is performed on non-sterile produced Cosmetic and personal care products. Specifically, which are produced according to harmonised pharmacopoeia or manufacturer’s in-house method is used to identify the bio-burden of the sample
- Total Bacterial Count:
- In this test, we are equipped to identify the bacterial count in the Surgical/Sutures/Medical devices which helps in determining the presence of microorganisms in said product. The identification criteria is CFU (colony forming unit) per gram or ml should not be greater than the specified guideline.
- Total Fungal Count:
- Indicates the presence of fungal
- Pathogen detection
- In produced food products pathogens may be referred to as infectious agents. Our microbiology laboratory is fully equipped and microbiologist has the expertise in identifying following pathogens:
- Algae
- Bacteria
- Fungi
- Prions
- In produced food products pathogens may be referred to as infectious agents. Our microbiology laboratory is fully equipped and microbiologist has the expertise in identifying following pathogens:
Packaged and unpackaged mineral water microbiological analysis
Our microbiology laboratory is well equipped and has experienced and expert human resource to carry out following microbiology analytical procedure outlined on Packaged and unpackaged mineral water:
- Bacterial Endotoxin Testing
- Our microbiologist has expertise in performing Limulus Amoebocyte Lysate (LAL) test on the produced Packaged and unpackaged mineral water to ensure that it is free from endotoxins
- Microbial Limit Test
- Usually, they said test is performed on non-sterile produced Packaged and unpackaged mineral water. Specifically, which are produced according to harmonised pharmacopoeia or manufacturer’s in-house method is used to identify the bio-burden of the sample
- Total Bacterial Count:
- In this test, we are equipped to identify the bacterial count in the Packaged and unpackaged mineral waterwhich helps in determining the presence of microorganisms in said product. The identification criteria is CFU (colony forming unit) per gram or ml should not be greater than the specified guideline.
- Total Fungal Count:
- Indicates the presence of fungal
- Pathogen detection
- In produced Packaged and unpackaged mineral water pathogens may be referred to as infectious agents. Our microbiology laboratory is fully equipped and microbiologist has the expertise in identifying following pathogens:
- Algae
- Bacteria
- Fungi
- Prions
- In produced Packaged and unpackaged mineral water pathogens may be referred to as infectious agents. Our microbiology laboratory is fully equipped and microbiologist has the expertise in identifying following pathogens:
Surgical/Sutures/ Medical Devices Testing
Our microbiology laboratory is well equipped and has experienced and expert human resource to carry out following microbiology analytical procedure outlined on Surgical/Sutures/Medical devices:
- Sterility testing
- To ensure that produced Surgical/Sutures/Medical devices are safe for human consumption we applied following procedures:
- Direct Inoculation
- Membrane filtration
- To ensure that produced Surgical/Sutures/Medical devices are safe for human consumption we applied following procedures:
- Bacterial Endotoxin Testing
- Our microbiologist has expertise in performing Limulus Amoebocyte Lysate (LAL) test on the Surgical/Sutures/Medical devices to ensure that it is free from endotoxins
- Microbial Limit Test
- Usually, the said test is performed on non-sterile produced Surgical/Sutures/Medical devices. Specifically, which are produced according to harmonised pharmacopoeia or manufacturer’s in-house method is used to identify the bio-burden of the sample
- Total Bacterial Count:
- In this test, we are equipped to identify the bacterial count in the Surgical/Sutures/Medical devices which helps in determining the presence of microorganisms in said product. The identification criteria is CFU (colony forming unit) per gram or ml should not be greater than the specified guideline
- Total Bacterial Count:
- Indicates the presence of fungal
- Pathogen detection
- In Surgical/Sutures/Medical devices pathogens may be referred to as infectious agents. Our microbiology laboratory is fully equipped and microbiologist has the expertise in identifying following pathogens:
- Algae
- Bacteria
- Fungi
- Prions
- In Surgical/Sutures/Medical devices pathogens may be referred to as infectious agents. Our microbiology laboratory is fully equipped and microbiologist has the expertise in identifying following pathogens:
- Antimicrobial Efficacy Testing
- Antimicrobial agents are those which can kill microorganisms. In this Antimicrobial Effectiveness test, it is ensured that the Surgical/Sutures/Medical devices have capability to kill microorganisms. Also, its repeated use is safe for humans.