- Analytical Laboratory
- Toxicology Laboratory
- Process Validation Lab
- Raw Material Centre
- Production Centre
- Research & Development
- Microbiological Laboratory
The analytical laboratory of CARe KERALAM Ltd is fully equipped to cater to the needs of the Ayurveda industry. The laboratory has all modern facilities for analysis of raw materials and finished products, method development and contract research. The major instruments are High Performance Thin Layer Chromatograph, High Performance Liquid Chromatograph, Liquid Chromatograph-Mass Spectrometer, Gas Chromatograph-Mass Spectrometer, UV-Visible Spectrophotometer, Fourier Transform Infrared Spectroscope and Inductively Coupled Plasma-Mass Spectrometer. They provide reliable, dependable and economical test results of samples submitted by the entrepreneurs.
- Water Analysis
- Spices and condiments
- Oils and Fats
- Phytochemical analysis
- Tea and Coffee
- Fruits and vegetables
- Cereals and pulses
- Bakery and Confectionary
- Honey and Honey products
- Nuts and Nut products
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, environmental analysis and identification of unknown samples. Substances that can be analysed are pesticide residues (45 nos), essential oils, fatty acids, methyl esters, residual solvents, forensic samples, 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 dentification, impurity identification, quantitative bioanalysis and quality control. LC-MS fingerprints of individual crude herbs or their mixtures can be developed. Identification and quantification of natural products and herbal extracts.
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, soil, 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) , clinical applications(lipids, metabolism studies, drug screening), cosmetics(identification of raw materials, preservatives, screening of illegal substances), food and feeds(quality control, additives etc.)
Toxicology is “the study of poisons.”(Or)Toxicology is the science that experimentally investigates the occurrence, nature, incidence, mechanism, and risk factors for the adverse effects of toxic substances.
Major Areas for Toxicological Studies:
- Agrochemicals and Petrochemicals
- Drugs and Pharmaceuticals
- Personal care products
- Packaging materials for drugs, food and farm products.
- Medical devices (Syringes, Catheters, Blood transfusion sets, Dialysis units, gloves, sutures etc.)
- Contraceptives (Copper T, Tubal rings, condoms etc)
- Genetically Modified crops and genetically modified organisms
- Dyes and Dye intermediates
- Toys and devices meant for children
- Herbal formulations and Ayurvedic drugs
Acute Toxicity Study
Acute toxicity describes the adverse effects of a substance that result either from a single exposure or from multiple exposures in a short space of time (usually less than 24 hours). To be described as acute toxicity, the adverse effects should occur within 14 days of the administration of the substance
Sub-Acute Toxicity Study
Sub-acute toxicity adverse effects are observed following repeated daily exposure to a chemical, or exposure for a significant part of an organism's lifespan (usually not exceeding 10%). With experimental animals, the period of exposure may range from a few days to 3 months.
The period of exposure may vary from 14 days to 90 days
Sub chronic toxicity study
Sub-Chronic toxicity adverse effects are observed following repeated daily exposure to a chemical, or exposure for a significant part of an organism's lifespan ..
The period of exposure 3 months
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.
Irritation Studies Chemicals
The surface effects of a chemical on the skin and the mucous membrane is important because accidental contamination is always a possibility, hence to check any such effects the following studies are performed
- Irritation to mucous membrane
- Primary skin Irritation
Repeated exposure of a test substance can activate the immunological system that can be activated by prior exposure and the response may be characterized by various external factors like erythema &edema.
This study gives information regarding the sensitization of the immune system towards a particular compound.
Reproductive Toxicity Study
Many chemicals can effect the fertility and reproduction, often in an insidous manner without any overt signs of toxicity. Fertility of males & females can be affected or adverse effects on the developing embryo or fetus may result due to the exposure of chemicals. Keeping in view the health of mankind as well as its progeny the following studies are conducted:
A. Segmental Studies
Segment I : Deals with the general reproductive performance of males & females.
Segment II: Teratogenicity
Segment III: Effect on lactating dams and pups
B. Two/Three Generation Studies
Main objective of this study is to check any neoplastic lesions caused by any compound when exposed for a prolonged period.
- OECD Guidelines for testing of chemicals
- ICH Guidelines
- Regulations of Schedule Y of Drugs & Cosmetics Act
- Regulations of Central Insecticides Board (CIB)
Routes of Administration
- Standard Routes of Administration Offered
- Guinea Pigs
- Haematology Analyzer - Biochemistry Analyzer
- various microscopes including Fluorescent microscope
- IVC system (animal House)
- Advance rotary microtome
- Deep freezer etc.
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.
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.
Our plant comprising of 5894 sq. ft. is designed taking into account man, material and process flow and as per GMP specifications.
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.
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.
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.
Raw Material centre
CARe KERALAM Ltd procures all the basic raw materials needed for production of ayurvedic medicines and supplies them to the consortium partners. This intervention helps to reduce exploitation of small and medium manufacturers by middlemen. A raw material store of 25,000 sq. feet area is devoted for this purpose. The CARe KERALAM team sources quality raw materials from different parts of the country.
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.
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
Orders and Enquiry
Contact : +91 9567356999 , Email : firstname.lastname@example.org
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.
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.
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.
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.
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 pioneer research organization in the field of Ayurvedic research, where all the infrastructure and expertise are available to develop new Ayurvedic medicines from their concept to market. It plays a pivotal role in the promotion of Ayurveda in the country. This organization has a wide spectrum of activities ranging from identification of raw materials to formulation of Ayurvedic products with reproducible efficacy.
Our R&D facility is recognized by the Department of Scientific and Industrial Research (DSIR), Government of India.
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.
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.
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 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)
- Colony count at 220c and 370c
- Pseudomonas aeruginosa
- Proteolytic and lipolytic bacteria
Water Analysis On Following Parameters:
- Bakery & Confectionery
- Wheat flour
- Baked products