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  • Analytical Laboratory
  • Small Animal Research Centre
  • Process Validation Lab
  • Raw Material Centre
  • Library
  • Production Centre
  • Research & Development
  • Microbiological Laboratory
  • Cluster Innovation Centre
  • Clinical Trials

Analytical Laboratory

Analytical services

CHEMICAL ANALYSIS

Ayush ProductsDrugs & CosmeticsFood & Agricultural ProductsHerbal ProductsProprietary Medicines• Nutritional Analysis• Vitamin Analysis• Food Additives • Added Synthetic Colours• Milk & Diary Products• Pesticide Residues• Heavy Metals & Trace Metals• Food Packaging Testing• Mycotoxins

WATER ANALYSIS

CHEMICAL ANALYSIS

Drinking waterProcessed Water STPETP

PHARMACOGNOSY

Plant AuthenticationMicroscopyMacroscopyPowder microscopyPhysico chemical analysisTLC/HPTLC Analysis QUALITY TESTINGRaw Materials In-Process ProductsFinished Products Release testing

SHELF LIFE / STABILITY STUDIES

Cross sectionalAcceleratedReal time/p>

Gas Chromatograph Mass Spectrometer (GC-MS)

Typical uses include testing the purity of a particular substance, or separating the different compounds of a mixture. Applications include drug detection, food and agricultural products, AYUSH products, environmental analysis and identification of unknown samples. Substances that can be analysed are pesticide residues, essential oils, fatty acids, methyl esters, residual solvents, flavours and fragrances.

High Performance Liquid Chromatograph (HPLC)

Can assay organic compounds; determine their purity and content of impurities. Vitamins, drugs etc. can be detected and quantified. Analysis of natural products and herbal extracts.

Liquid Chromatograph-Mass Spectrometer (LC-MS)

Pharmacokinetics studies/bioanalysis Study of proteomics Drug development at different stages including natural products dereplication, bioaffinity screening, in vivo drug screening, metabolic stability screening, metabolite identification, impurity identification, quantitative bioanalysis and quality control. LC-MS fingerprints of individual crude herbs or their mixtures can be developed.

Ultraviolet-Visible Spectrophotometer

Quantitative determination of different analytes, such as transition metal ions, highly conjugated organic compounds, and biological macromolecules. Advanced pharmaceutical testing including quantification of active ingredients.

Inductively Coupled Plasma -Mass Spectrometer (ICP-MS)

Inductively coupled plasma mass spectrometry (ICP-MS) is mainly used for rapid, precise and accurate trace element determinations in liquid and solid samples. Elemental analysis in herbs, ayurvedic formulations, spices, drinking water, waste water, food, cosmetics etc. at different levels (from ppb to ppt).

Fourier Transform Infrared Spectroscope (FTIR)

Identification and quantification of organic functional groups and specific organic and inorganic compounds. Identification of additives in polymers, when they can be chemically removed. Measures unknowns, conducts trace level chemical analysis, Identifies quality problems and root-cause quality issues, screens raw materials, characterizes trace impurities, contamination and chemical compounds, supports chemical and material research and more.

High Performance Thin Layer Chromatograph (HPTLC)

Simple, flexible and cost-effective separation technique for both qualitative and quantitative analysis, enabling simultaneous analysis of many substance with minimal time requirement. Application field includes pharmaceuticals (quality control, purity check, stability test), herbals (Identification, adulteration, assay of marker compounds),cosmetics (identification of raw materials, preservatives, screening of illegal substances), food and feeds(quality control, additives etc.)

Small Animal
Research
Centre

Adequate facilities exist in our laboratory and animal house to perform various toxicological and efficacy studies of drugs, pharmaceuticals and neutraceutical formulations.

The facilities in the Toxicology Department are;

Animal house

  • CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals, under Govt. of India) registered laboratory animal house facilityto conduct research on various experimental animals like rodents and rabbits.
  • Well-maintained and spacious animal rooms with 24hr air conditioning facility
  • Separate rooms for different laboratory animal species.
  • Animals maintained under hygienic conditions
  • Individually Ventilated Caging (IVC) System - for housing laboratory animals

Laboratory

To perform analyses on various samples collected from the experimental animals. Major equipments available in the toxicology laboratory include;

  • Auto Analyzer - for Serum Biochemistry
  • Haematology cell Counter
  • Lyophilizer or Freeze Dryer – freeze-dry system used to remove solvent from frozen samples, (eg. plant extracts)and it can be preserved for long
  • Histopathology Processing Unit for the microscopic examination of tissues

Institutional Animals Ethics Committee (IAEC)

  • A committee recognized and registered by the CPCSEA
  • To review and approve all types of research proposals of lab animal experimentation before the start of the study.

Institutional Scientific Advisory Committee (ISAC)

  • A committee of in-house scientific personals and one external expert advisor
  • To review and modify the research proposals before submitting to the IAEC.

Chronic Toxicity Studies

Chronic toxicity adverse effects are observed following repeated exposure to a chemical during a substantial fraction of an organism's lifespan (usually more than 50%). For humans, chronic exposure typically means several decades; for experimental animals, it is typically more than 3 months. Chronic exposure to chemicals over periods of 2 years using rats or mice may be used to assess the carcinogenic potential of chemicals.

IPreclinical studies -An overview

Toxicological Studies:

  • Acute (single dose) toxicity studies
  • Sub-acute and sub-chronic (repeated dose) toxicity studies
  • Chronic (repeated dose) toxicity studies
  • Irritation studies
  • Allergic sensitization
  • Reproductive toxicity studies

Efficacy studies conducted in our Lab:

  • Analgesic and Anti-inflammatory activity
  • Hypolipidemic activity
  • Hepatoprotective activity
  • Anti-ulcer activity
  • Wound healing activity
  • Cardio protective activity
  • Immunomodulatory activity
  • Anti convulsant activity
  • Other pharmacological studies

Facilities for students

Small Animal Research Centre (Department of Toxicology & Pharmacology) at CARe Keralam Ltd. offers a good opportunity to students/research scholars in life science/related fields,

  • To carry out their dissertation and project works in Pharmacological/Toxicological studies by utilizing the superior facilities present in the department.
  • Training on laboratory animal handling and experimentation techniques

Main toxicological Study Designs

1.ACUTE TOXICITY STUDY

Single-Dose Toxicity Study based on OECD Guideline 420

Experimental animals Laboratory rodents(rats, mice)/rabbits
Total Animals 6 Female animals
Dose Frequency Single dose
Dose Route To be specified (ex. oral, bolus iv, infusion, subcutaneous injection, intraperitoneal injection, topical, ocular, etc.)
Study Duration 14 days
Clinical Observations Daily
Body Weights Weekly
Necropsy Gross examination
Histopathology Lesions as applicable; as specified by Sponsor (i.e. Lesions only, target organs, or main organs); Standard histology includes paraffin embedding and slides prepared with H&E; additional charges will be incurred for preservation, processing, and evaluation
Deliverables Report with observations and dose administration table for in-life phase, as well as any gross observations, and pathology results, as applicable.

2.REPEATED DOSE TOXICITY STUDIES

a)Subacute Toxicity Study based on OECD Guidelines

Main study Recovery
Groups Males Females Males Females
Laboratory rodents Control 5 5 5 5
Low 5 5 0 0
Mid 5 5 0 0
High 5 5 5 5
Total no. of animals N = 40 N = 20
Dose Route To be specified (ex. oral, bolus iv, infusion, subcutaneous injection,intraperitoneal injection, topical ocular, etc.)
Dose Frequency Daily for 28 days
In-life Study Duration 28 days dosing, plus Recovery Period (i.e. 14 days)
Dose formulation As specified by Sponsor—additional charges may apply

Evaluation parameters

Clinical Observations Daily
Food Consumption Weekly
Water Consumption Weekly
Body Weights Weekly
Clinical Pathology Blood Collection from main animals and recovery animals (if applicable) at sacrifice; standard panels include for clinical chemistry, hematology,
Necropsy Main and recovery animals
Tissue Preservation Standard tissues (per OECD guidelines) stored in formalin
Histology/Pathology Standard tissues of animals in main and recovery groups; Sponsor to specify request for histopathology on all tissues or preserved tissues

b)Subchronic Toxicity Study based on OECD Guidelines

Main study Recovery
Groups Males Females Males Females
Laboratory rodents Control 5 5 5 5
Low 5 5 0 0
Mid 5 5 0 0
High 5 5 5 5
Total no. of animals N = 40 N = 20
Dose Route To be specified (ex. oral, bolus iv, infusion, subcutaneous injection,intraperitoneal injection, topical ocular, etc.)
Dose Frequency Daily for 90 days
In-life Study Duration 90 days dosing, plus Recovery Period (i.e. 28 days)
Dose formulation As specified by Sponsor—additional charges may apply

Evaluation parameters

Clinical Observations Daily
Food Consumption Weekly
Water Consumption Weekly
Body Weights Weekly
Clinical Pathology Blood Collection from main animals and recovery animals (if applicable) at sacrifice; standard panels include for clinical chemistry, hematology,
Necropsy Main and recovery animals
Tissue Preservation Standard tissues (per OECD guidelines) stored in formalin
Histology/Pathology Standard tissues of animals in main and recovery groups; Sponsor to specify request for histopathology on all tissues or preserved tissues

Study sample processing

  • Identify the category of your “Product” and its potential by Business Development Executive CARe Keralam
  • BD Communicates to Department
  • Cost of Study, Duration, Volume of Samples, Certificates needed will be informed
  • Sign work order
  • 50% of Study Cost as Advance
  • Preparation of Protocol (Form B) by Scientific Committee, CARe Keralam.
  • Approval from Institutional Scientific Advisory Committee (ISAC)
  • Approval from Institutional Animal Ethics Committee (IAEC)
  • Study conduction
  • Recording of Observations and Statistical Analysis of Data
  • Interpretation of results and report preparation
  • Release of Study Report on final payment
Animal Studies Toxicology Laboratory - Care Keralam

Process Validation

With advent of modern machines and the need to produce on a commercial scale increasing in Ayurveda,there exists a lacunae in uniformity in method of manufacturing. A trial and error method is being followed , which may even compromise the core ingredient of the formulation.

These have resulted in batch to batch variation in final products . At our validation lab we will help you, through our pilot scale production, to arrive at a documented ,uniform, manufacturing process, scaling up process, economic process development.

We also provide consultancy on new product development of Arishtas, Asavas, Grhithams, Tablets, Liquids, Syrups, Powders, Creams & Ointments. A trial pilot batch will be take in presence of the client, as the last stage of consultation.

Production

Our plant comprising of 5894 sq. ft. is designed taking into account man, material and process flow and as per GMP and WHO specifications. It is equipped with high end machineries for softgel encapsulation, tableting and blistering of multi vitamin, mineral, nutraceutical and ayurvedic products.

  • Herbal Ayurveda Preparations
  • Cosmeceuticals Development
  • Formulations
  • Contract Manufacturing
  • Process & Product Standardization
  • New Product Development
  • High Quality Rawmaterials
  • Tablet Coating

Encapsulation Facility

We have a state of art encapsulation facility. The floor is polyurethane coated and the walls are puff insulated. Our encapsulation machine is a jumbo model of Chang Sung make, with a capacity to encapsulate 100000 capsule/hr. This a boon to the ayurvedic Industry as many dosage forms in oil phase can be converted into aesthetic soft gel capsules.

Tablets/Coated Tablets/Extract’s Tablets

A 16 station granulation machine takes care of all the compression requirements when the granules are provided to us as per the pre-approved validated formula.

Blister Packing

Packing, which is one of the important criteria that adds to shelf life of a product, is taken care by our blister packing machine with a capacity of 240 packs/minute.

Softgel Encapsulation

The medicine in a liquid or semi-solid state supplied by the entrepreneur is converted into soft gelatin capsule form. Applications: Traditional oil, ghee, ghritham fillingNeutraceuticalsMultivitamins, Vitamin E, Honey etcTableting

The medicine supplied as dust or granules is compressed into tablets along with excipients and lubricants to ensure efficient tableting.Applications:Extract tablets, Herbal tablets,Coated tablets, Various patented tablets, Clasical tablets

Range of Size & Shape of Tablet:75mg to 750mg, round and oblong

Blistering & Bottling

Facility for Blister packing and Bottle packing of Soft gelatin capsules and tablets.Range of Blister Dye: 6, 8, 10, 11.5, 12.5,15 mm tablets and 4, 10 oval soft gel capsule and 22 oblong and zero size hard gel capsule

Semi Solid Formulations

  • Creams
  • Lotions
  • Gels
  • Ointments
  • Balms
  • Lip balm

Raw Material centre

Raw Material Laboratory

The quality of the raw materials procured is assessed in the Mini Lab attached to the raw material store. As soon as raw materials arrive, samples are drawn and brought to the Mini Lab, where they are subjected to detailed testing. Only those raw materials that conform to the specifications will be accepted.


Here we ensure that the raw materials comprising medicinal and aromatic plants, essential oils, fixed oils and extracts that go into formulations are authenticated with respect to pharmacognostical specifications. All the crude drugs are identified and authenticated through pharmacognostical studies. Herbaria are prepared from a collection of wide range of plant specimens from different parts of the country. Crude drug museum is an integral part of our pharmacognosy laboratory and serves the purpose of authentication. We are preparing monographs for all the raw materials as per pharmacoepial guidelines by detailing their morphology, microanatomy and powder characteristics.


Raw Materials - Care KeralamRaw Materials List Raw Material Laboratory - Care Keralam

Pharmacognosy of a crude drug/powdered drug

The following are the steps taken for detailed study of each raw drug:

  • Identification of drug origin
  • Identification test for crude drugs
  • Identification of organoleptic characters
  • Macroscopic and microscopic characters
  • Phytochemical analysis
  • Determination of foreign matter
  • Determination of moisture
  • Adulterant studies
  • Examination of powdered drug

Library

The library has a collection of books on Ayurveda and other related subjects, popular magazines and journals. Ayurveda Tomorrow is an in-house publication of CARe KERALAM Ltd.

  • Manuscripts
  • Original Monographs
  • Primary, Secondary, Tertiary Reference materials

Library - Care Keralam

Production Centre

The Production Department of CARe KERALAM is committed to provide affordable Ayurvedic pharmaceutical products of global quality standards to its customers. With extensive technical expertise and complete training to its staff we have already entered the business of conversion for Granulation, Formulation, Tableting, Encapsulation of soft gelatin capsules and blister packing of tablets, hardgelatin and softgelatin capsules by advanced technological processes and remarkable product quality.

Services

SOFTGEL ENCAPSULATION : The medicament supplied by the entrepreneur is converted into soft gelatin capsule form. Soft gelatin capsule is the most versatile of all dosage forms. The one piece, hermetically sealed soft gelatin shell containing medicament in a liquid or semi-solid state which is filled and sealed in one continuous operation is called encapsulation. The soft gelatin capsule is also called as "one piece" capsule.

Production Centre - Care Keralam

TABLET COMPRESSION : The medicament supplied as dust or granules is compressed into tablets. It can be in pharmaceutical dosage or food supplement and also include excipients such as diluents, binders or granulating agents, glidants (flow aids) and lubricants to ensure efficient tableting. Medicinal tablets and capsules are often called "pills".

 

BLISTER PACKING : Soft gelatin capsules and tablets are blister packed in HDP or Aluminium foils.

 

FORMULATION : The formula ingredients are fairly dry, powdered or granular in form and should be Uniform in particle size, and freely flowing and the Content uniformity ensures that the same API dose is delivered with each tablet.

 

Inactive ingredient (excipient) termed a binder is added to help hold the tablet together and give it strength. Binders such as lactose, dibasic calcium phosphate, sucrose, corn (maize) starch, microcrystalline cellulose, Povidone and modified cellulose are used. Ingredients are also needed to act as disintegrate to aid tablet dispersion once swallowed, releasing the API for absorption. Some binders, such as starch and cellulose, are also excellent disintegrants.

 


Facilities

16 STATION TABLETING COMPRESSION MACHINE : The compression machine is a single rotary SMD3-16 GMP machine. It is a 16 station machine with an output of 40,000 tablets per hour. The machine has capability to produce good quality tablets up to 25mm diameter and 20mm depth in size.

The supportive equipment's for tableting include CMJ-8 Granulator with output of 200 kg per hour, Sieving, Grading and Straining (SIFTER) machine of CSGS-500 model, Cad mill of CMC/CM model and Mixer of CMH model and are manufactured according to standard GMP.

 

BLISTER PACKING MACHINE : The RAPID PACK RP 240 is an automatic blister pack machine and is utilized for packing of tablets, soft gelatin and hard gelatin capsules. The blister forming, filling and sealing operations are continuous by rotary motion and indexing and punching operations are intermittent in nature. In case of slightly rounded or flat tablets up to 10 mm diameter an output of 240 packs per minute can be achieved.

 

SOFT GELATIN ENCAPSULATION UNIT : This state of art Korean encapsulation machine from Chang Sung is manufactured according to the regulations of FDA and GMP and can manufacture oval,oblong, and round soft gelatin capsules of any color and the die roll is designed in zigzag to save gelatin and the large number of pockets packed in die roll enhances productivity and has capacity to produce up to 1lakh 30 thousand capsules per hour and also has a six stage tumble drier system.

Our Drying system is totally controlled by the AHU and DHU system and maintains highly precise room conditions required for the soft gelatin capsules.

 

The Supportive equipment for the manufacturing of softgelatin capsules are the 500kg Melting unit, Melting tank,Colloidmill,Homogeniser, Colour mixing stirrer, sorting machine and the polishing machine which serves as the pre and post encapsulation machines for giving high quality capsules to our esteemed customers.

We have in-house quality control system of Precision balance for accurate measuring of capsules, DT Apparatus, Visco meter, Moisture balance and leak test apparatus for our IPQA process and all quality process are done inhouse according to GMP and WHO standards.

Research & Development

CARe Keralam is a pioneering research institution in the field of Ayurvedic research, with all of the necessary infrastructure and experience to bring innovative Ayurvedic medications from concept to market. It is critical to the advancement of Ayurveda in the country. Research and development is the brain and backbone of any Life science companies. Our R&D department has been involved in the research, development, and commercialization of ayurvedic health products based on Ayurveda and current scientific approaches. The process includes a wide spectrum of activities ranging from identification of raw materials to formulation of Ayurvedic products with reproducible efficacy.

Despite the good intentions of government organisations, research in ayurveda and herbal medicines of Indian origin, as well as converting that research into commercial medicine, is languishing in the country. In an era of rising consumer awareness of quality and efficacy as well as market competitiveness, we believe that existing products must be strengthened utilising an innovative approach as well as new advancements. It is active in a variety of operations connected to Ayurveda research, herbal pharmaceuticals, nutraceuticals, and phytochemicals employing current scientific and technological approaches while retaining efficacy, safety, and Ayurveda principles.

CARe Keralam Ltd seeks to provide technical assistance in a variety of areas of healthcare research, including the creation and validation of herbal and phytopharmaceuticals, as well as the application of advanced techniques in the plant, microbial, and healthcare industries. We offer technical assistance with pre-clinical compound screening, formulation development, and clinical validation. We also provide professional, student, and researcher skill development through training / internships.

The R&D unit has a team of Doctors, Scientists, and experts from Ayurveda, Botany, Pharmacognosy, Biotechnology, Microbiology, Pharmacology, Chemistry, Herbal Drug Discovery, etc.

Herbal Garden

We are establishing a herbal garden of various types of plants to popularize the usefulness of Medicinal Plants among the research community. Our supreme aim is conserving rare, endangered and threatened species of medicinal plants. The herbal garden of CARe Keralam is spread out in an area of 1 acre of land where more than 250 species of medicinal plants are grown. A part of the herbal garden has been earmarked exclusively for growing herbs required for the research division of Institution.

Recognition of R&D Laboratory

In realisation of the achievements of our R&D Laboratory, the Department of Scientific and Industrial Research (DSIR), Government of India has granted it recognition and formal certification to our laboratory.

Completed Projects:

SN Title of the project Name of Division and funding agency Date of completion / status Objective
1 Dossier on Nishaakathaka di Kashayam’ A project carried out in collaboration with National Innovation Council and Department of scientific and Industrial research Government of India February 2013 Efficacy in diabetics
2 Dossier on Akulyabdadi Kashayam Traditional Knowledge Innovation Kerala, under the Directorate of Ayurveda Medical Education, Govt. of Kerala October 2015 Efficacy in diabetics
3 Dossier on Punarnavadi Ghritham Traditional Knowledge Innovation Kerala, under the Directorate of Ayurveda Medical Education, Govt. of Kerala March 2017 Efficacy in Liver disorder.
4 Validation of Safety, Efficacy and Quality and Preparation of Drug Master File of Classical Ayurvedic Formulation Vasaguduchya di Kashaya and Katakakhadira di Kashaya. Ministry of AYUSH, Govt. of India, under EMR Scheme November 2018 Efficacy in Liver disorder & Diabetics
5 Development Of Pharmacopoei al Standards For Ayurvedic Formulations (A project by the Pharmacopoei al commission of Indian Medicine and Homeopathy) Pharmacopoeial commission of Indian Medicine and Homeopathy, Ministry of AYUSH, Govt. of India Completed 9 monograph s out of 10 Standardization of Ayurvedic formulation.
6 Antidiarrheal formulation Coconut Development Board, Govt. of India Completed on March 2018 Anti-diarrheal activity of CKCD001
7 A multicenter Clinical Trial of Akulyabdadi Kashayam and Kashayam tablet in Diabetes mellitus Traditional Knowledge Innovation Kerala, under the Directorate of Ayurveda Medical Education, Govt. of Kerala Completed on November 2018 Efficacy in diabetics
8 Dossier on Parjjani Ghritham and Parjjani Kashayam Traditional Knowledge Innovation Kerala, under the Directorate of Ayurveda Medical Education, Govt. of Kerala Completed on March 2019 Efficacy in urinary disorder & kidney function.

Ongoing Projects

SN Title of the project Name of Division and funding agency Date of completion / status Objective
1 Immunostimulatory formulation to treat upper respiratory tract infections in children. Coconut Development Board,Govt. of India On going Immunomodulatory activity of CKCD002
2 Litholytic formulation to treat Kidney stones. Coconut Development Board,Govt. of India On going Anti litholytic activity of CKCD003

R&D Capabilities

Our R&D laboratory is well equipped to carry out modern research in various areas of life Sciences. We follow the standard guidelines and protocols for all the scientific studies. Some of the areas of our R&D activities are:

  1. New Product development
    • Drug selection, Identification, Extraction, Isolation and Characterisation
    • Chemical/Spectral/ Analytical studies
    • Clinical trials, Pilot studies, Randomized clinical trials, Post Marketing (PMS) study
    • In vitro studies ,Cell line studies
    • Preclinical studies, Toxicology Pharmaceuticals, Cosmeceuticals, Nutraceuticals & Others
    • Development and evaluation of pharmaceuticals, Cosmeceuticals, Nutraceuticals & Others
    • Process validation & optimization
    • Characterization and identification of biomarkers
    • Fingerprinting studies with HPTLC, HPLC, etc.
    • Standardization of herbal as well as ayurvedic medicines.
  2. Process Development
    • Development of herbal and modern ayurvedic formulations
    • Preformulation Process
    • Formulations Process
    • Packing and Storage process
    • Economic Process Development
  3. Technology Development
    • Industry set up
    • Fabrication of Machines
    • Customised Machines & Equipments
    • Economic and Viable Technology development
  4. Problem Solving
    • Existing Product /Formulation/Process related problems
    • Conversion of existing products to new formulations
    • Stability, Palatability, Aesthetic improvement
    • Packaging, Storage, Shelf life Modifications
    • All type of running problem solving
  5. Project development
    • Assisting funded/Non funded projects
    • Dealing new projects
    • Completion of Existing projects
  6. Academic Services
    • Research support for UG, PG & PhD scholars.
    • Training program for Professionals, Industrialists, and Students.
    • Seminars
    • Publications
    • Intellectual Property Registration
    • Projects
  7. Professional Services
    • New Formulations
    • Customized products
    • Process development
    • Process & Product Standardization
    • Advanced technology
    • Regulatory services
    • Licensing services
    • Patenting
    • Copyright& trademark
  8. Standardised Raw materials Supply
    • Certified
    • Standardised
    • Genuine
    • Authentic
    • Pesticide & Heavy metal free reference materials
    • At Affordable price Ready to use – No need to rewash or redry.
  9. Medicinal Garden/ Herbarium
    • Plant authentication
    • Botanical/ taxonomical identification
    • Pharmacognostic studies
    • Agronomy/Agricultural services
    • Plant Tissue culture studies
    • Taxonomically identified spices. more than 200 species on display
Research & Development - Care Keralam

Microbiology Laboratory

Microbiological criteria are used to indicate the required microbiological status of raw materials, ingredients and end-products of herbal medicine industry. Microbiological criteria are applied to define the distinction between acceptable and unacceptable raw materials and products. At CARe KERALAM Ltd we analyze the microbial status of raw materials used in Ayurveda industry and the finished products. The analyses are in line with the standards set by Ayush, W.H.O. and U.S.F.D.A. Using internationally accepted test methods we enumerate total aerobic bacteria, total yeasts and moulds and specific organisms such as Escherichia coli, Salmonella spp., Pseudomonas aeruginosa and Staphylococcus aureus.

Sophisticated instruments such as TEMPO, and Mini VIDAS are used for precise and faster results.

Microbiology Analysis - Care KeralamMicrobiology Analysis Microbiology Laboratory - Care Keralam
Mini VIDAS - Care Keralam

Mini VIDAS

The VIDAS range is greatly appreciated worldwide for its simplicity, flexibility and accuracy. VIDAS is the world�s leading automated system for food-borne pathogen detection with tests for Escherichia coli O157 (Including H7), Salmonella, Listeria spp., Listeria monocytogenes, Staphylococcus enterotoxins and Campylobacter. VIDAS and mini VIDAS are multiparametric systems using ELFA (Enzyme Linked Fluorescent Assay) technology with a final blue fluorescent reading. This technology ensures excellent result sensitivity and specificity and is based on a ready-to-use single-sample test concept.

 

VIDAS Salmonella is a rapid method for the detection of Salmonella,
delivering results in as little as 17 hours, where traditional methods can take up to 3 days.

 


TEMPO - Care Keralam

TEMPO

The agri-food industry routinely enumerates microbial flora, which indicates the microbiological quality of the entire production process, from raw materials to finished products. TEMPO is the first automated solution for direct quality indicator enumeration in food products. One TEMPO configuration can perform up to 500 tests per day. The TEMPO solution is composed of two work stations - a preparation station and a reading station.

 


TEMPO Preparation Station - Care Keralam

TEMPO Preparation Station for inoculation, with distribution of a diluted food sample in culture media, then filling and sealing of TEMPO cards using the TEMPO filler.

 

TEMPO Reading Station for reading and interpretation of TEMPO cards using the TEMPO Reader.

 

With TEMPO, results are faster than conventional methods (i.e: 24 to 48 h), providing more rapid selection and orientation of raw materials, accelerated corrective actions in case of non compliance, speedier product release and improved stock rotation.

 

The TEMPO card covers several dilutions, so only one TEMPO test is needed instead of multiple plates to obtain the most relevant result according to each criterion. It also eliminates time consuming tasks such as media preparation, manual dilutions and identifications.

 


 

MICROBIOLOGY LAB SERVICES

AYURVEDIC RAW MATERIALS & FINISHED PRODUCTS:

  • Avaleha / Leham / Modak / Ilagam (Confectionary/ semi solid)
  • Churna / Choornam / Kwatha choorna / Kudinir choornam (Coarse powder for decoction)
  • Asava & Arishta (Fermented Liquids)
  • Plant extract
  • Lepa / Malhara / Kalimbu / Pasai / Medicated wax/ Cream/ Poultice
  • Pishti / Bhasma / Parpam / Sindur (Processed fine powder)
  • Sharkara siktha / Siruthugalgal (Granules)
  • Sharbat/ Manappagu (Syrup)
  • Raw plant material
  • Lotions / Shampoo
  • Vadi / Gutika / Kuligai / Marthirai / Vadagam (Tablet/ Pills)

 


 

    Water

  • Water for Processed food industry
  • E.coli
  • Swimming pool water

    Food & Agricultural products :

  • Herbs, Spices & Condiments
  • Bakery & Confectionery
  • Honey
  • Tea
  • Coffee & Cocoa products
  • Fruit & Fruit products
  • Vegetable & Vegetable products

Antimicrobial Analysis

Hygiene Monitoring

  • Air hygiene monitoring
  • Surface hygiene testing

Cluster Innovation Centre

The Cluster Innovation Centre (CIC) supported by the National Innovation Council (NInC), Government of India, promotes innovation leading to entrepreneurship which will benefit to the people at large having potential for successful marketing. CIC in CARe KERALAM is the only Ayurveda cluster in the country, selected by NInC, for the promotion of ayurveda products and services to the global market, at international standards. The Cluster Innovation Centre (CIC) provides a platform for CARe KERALAM and its partners to forge linkages between various stakeholders from industry, academia, research institutions, professional service organizations, Government & non-Government agencies and society on a need basis. With a team management structure, this centre will aid the cluster and its ecosystem by providing guidance to various start-ups on all aspects of the innovation process including training and support, organize initiatives to promote innovations, knowledge/technology transfer, channel various incentives that benefit the cluster and act as an incubating body managing the growth of innovation in the ecosystem.The Centre will serve as a networking hub of the cluster, acting as a catalyst and a facilitator to initiate and assist innovation activities the 'decade of innovation' 2010-2020.

Objectives

  • Promote Innovation
  • Support Entrepreneurs

Beneficiaries

  • Potential entrepreneur
  • Investor
  • Inventor
  • Innovator
  • Students
  • To act as a connecting point Establish any new entrepreneur ventures by supporting in the following areas.
  • Identifying investment area
  • Development of product
  • Detailed Project Report (DPR)
  • Intellectual Property Rights (IPR)
  • Funding
  • Plant Establishment
  • GMP Certification
  • Product Registration
  • Marketing
  • Investor
  • Inventor

Activities

Role of the Cluster Innovation Center (CIC)

  • Research
  • Finance
  • Industry &Professional Bodies
  • Finance
  • Government
  • Agencies
  • Sectoral Experts

CIC - The connector

  • All "internal" units
  • All "External" orgs
  • Collaboration, Coorperation, Networking

CIC - The chaneel

  • R & D, Skills, Mentors, Financiers, Experts

CIC - The leadership

  • Catalyze, Facilitate and manage innovation activities on daily basis

Innovation Promotion Units (IPU)

Innovation Promotion Units are aimed at giving support needed to students and faculty in fostering an ecosystem of innovation as well as connecting research and curriculum with applications for the benefit of industry and society. Thus the centre shall provide a platform for taking up innovation-driven projects. This centre will provide guidance in all aspects of the innovation process including training and support, organize initiatives to promote innovations, knowledge/technology transfer, channel available resources and act as an incubating body, managing the growth of innovation in the ecosystem. It will therefore act as a hub for Innovation activities that could lead them into Entrepreneurship, by facilitating and guiding development of ideas into innovative applications that can be marketed successfully.

In an effort to promote entrepreneurship and innovation among students, the Kerala government has announced its Student Entrepreneurship Policy. On this occasion Honourable Chief Minister of Kerala said "Any student who works to create knowledge, innovation, wealth and jobs in our Society through any Government of India recognised Incubators will be given 20% attendance and 4% Grace Marks in the Academic Courses" similar to what is being given to Sports and NCC. We expect this will give the students time to pursue innovation leading to entrepreneurship during their studies and the best of talent now flows into the proposed Innovation Promotion Unit. To emerge as a strong and vibrant economy, Kerala has to emerge from within and empower our talented youngsters to be job-creators and not job-seekers". This could also provide colleges with an opportunity to involve themselves in projects, research and development with industry thereby strengthening their institution and providing industry with value addition in the form of academic research.

CIC functioning at CARe KERALAM can provide complete solutions for all the innovative ideas/entrepreneurs.

Clinical Trial Facility

Our clinical trial centre can help you with all aspects of medication development. We specialize in Phase I to Phase IV clinical trials of herbal pharmaceuticals and other alternative therapies, as well as their strategy planning, management, execution, and analysis. Our department is prepared to carry out post-marketing surveillance, human clinical research, and all other clinical research and studies in an efficient, ethical, and scientific manner in order to improve medical treatment for the entire world.

Our experts focus on

  • Drug development
  • Preclinical studies (Toxicology, Safety & Efficacy studies) Bioavailability -Bioequivalence ((BA/BE) studies Pharmacokinetic- Pharmacodynamic (PK/PD) studies
  • Clinical Research
    • Clinical Trials - Phase I to Phase IV, BA/BE studies, (PK/PD) studies. Adverse drug events/ Adverse drug reactions (ADE/ADR), Pharmacovigillance. API (Active Pharmaceutical ingredient) clinical trials.
    • Post marketing surveillance (PMS), Post marketing requirement (PMR), Pharmacoeconomic studies, Cost analysis.
    • Pilot Studies, Case Studies, Case/Control Studies, Cohort studies, Systematic Scientific Studies, Blinded studies.
  • Clinical studies (as per ICH-GCP guidelines) on Ayurvedic Proprietary Medicines, Classical Ayurvedic Medicines, Herbal formulations, Allopathic medicines, Functional Food / Supplements, Nutraceuticals, Cosmetic products and Homeopathic, Sidha,Unani medicines.
  • Clinical Trial Budgeting/ Project/Protocol Preparation.
  • Clinical Validation of traditional/Folk medicine

Biostatistics service

  • Preparation of Study Design
  • Determination of sample size
  • Interim Analysis
  • Final Analysis & Report
  • Data Management / Processing

Medical writing

  • Preparation of Protocol
  • Investigator Brochure (IB)
  • Collaboration, Coorperation, Networking
  • Case Report Forms (CRFs)
  • Informed consent form (ICF)
  • Subject Diaries
  • Study logs (delegation log, IP logs etc.)
  • Manuscript Preparations
  • Publications

Regulatory submissions

  • Drugs Controller General of India (DCGI) Submissions
  • AYUSH Submission
  • Ethics Committee (EC)submissions
  • CTRI (Clinical Trials Registry-India) Registration
  • Clinical Trials Registry- US
  • Clinical Trials government Registration
  • Clinical Trial Presentation
  • Repurposing Process

Documentation

  • Documentation of clinical trial (TMF, PMF, SMF)
  • Quality System Management
  • Case Report Forms (CRFs)
  • DSOP Development
  • Data Collection, Retrieval, Auditing

Operations

  • Site selection, Site management & Site closing
  • Trial Management
  • IP and Trial Material Management
  • Data Management
  • Monitoring
  • Clinical Study Report
  • Investigator’s Training
  • ICH- GCP Training