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MANUFACTURING FACILITIES


Bakson Drugs and Pharmaceuticals Pvt. Ltd. is one of the leading manufacturers of Homoeopathic Medicines and has two functional units at Parwanoo (Himachal Pradesh) and Roorkee (Uttarakhand). The plant at Roorkee is a result of our expansion plan and has been newly commissioned as per GMP norms. We have a production capacity of over 200000 sq ft. Under the esteemed guidance of Dr. Bakshi, we have achieved an enviable position in the Homoeopathic pharmaceutical industry. Located in the natural environs, working day in and day out to maintain the standards as a promising Industry and always thriving for the best, Bakson has grown tremendously over a short span of time. All our efforts are a strong commitment towards ensuring safe and effective cure for the ailing masses by providing quality Homoeopathic Products. Bakson Drugs & Pharmaceuticals Pvt. Ltd. is engaged in manufacturing wide range of Homoeopathic Medicines, Mother Tinctures, Dilutions, Biocombinations, Biochemics, Specialty Medicines, Ointments, Creams, Gels, Veterinary Medicines & Pet Products. It is also engaged in manufacturing of Sunny's Hair & Skin Care range of Cosmetics.


OUR ASSETS

Bakson ensures unmatched quality of all its products. It strictly adheres with the pharmacopoeial standards for producing medicines to cater to the growing requirements of value added medicines.


PROFESSIONAL CARE

In its aggressive pursuit for excellence, every procedure at Bakson is monitored by a consortium of professionally qualified pharmacists, chemists, botanists and homoeopaths.


RAW MATERIAL

We import herbs, from the countries of their original habitat to avail maximum benefits of the active principles in their natural biological forms. Medicines are also prepared from animal sources as well as chemicals conforming to pharmacopoeial standards.

We believe in fresh collection and usage of herbs in manufacturing of Mother Tinctures. In order to maintain their therapeutically active components and also to avoid difficulties in inventory maintenance, we have a complete floor allotted to store herbs including separate place for odorous, poisonous, imported and indigenous herbs. They are kept well sealed under optimum storage conditions i.e. away from moisture, heat and light.


EXTRA NEUTRAL ALCOHOL

We use the best known alcohol i.e. Extra Neutral Alcohol (E.N.A.), for expressing the active constituents and preparing Mother Tinctures, Dilutions as well as other specialties. Mother Tinctures are prepared in exact percentage of alcohol as per standards of Homoeopathic Pharmacopoeia. As compared to rectified spirit, ENA scores better in terms of:

  • Quality
  • Purity
  • Flavour
  • Visual impact

Bakson is the largest consumer of E.N.A. in Asia.

We procure Extra Neutral Alcohol of export quality which is one of the best analytically as well as organoleptically.

The complete test for alcohol including absence for methyl alcohol and steroids are carried out for raw material and also for finished product.

The analysis of alcohol is done by chemical methods and also instrumentally through Gas Chromatography which gives the graph for presence and percentage of impurities thereof.


LACTOSE

Pharmacopoeial grade, high class lactose is used for all our tablet preparations. We import HMS Lactose which has superior consistency, purity & clarity thus ensuring uniformity of tablets. This also helps in quick dissolution and thus better action of remedies.


WATER

We have DM Plant from one of the leaders in water treatment plants for wide range of applications. In addition, for sterilization we also have a system of passing the DM Water through UV water treatment. It offers many advantages over other forms of water treatment for microbiological contaminants. Most importantly, it does not introduce any chemicals to the water, it produces no bi-products and it does not alter the taste, pH or other properties of the water.


HI-TECH PROCESSES

  • Accurate estimation of moisture content done by the use of Electronic Infrared Moisture Analyser.
  • Mother Tinctures prepared through Maceration & Percolation. Hi-tech Hydraulic Presses are used for their extraction.
  • Natural colour of mother tinctures is preserved by highly standardized methods.
  • Automatic, computerized Potentizer used to prepare Back potencies.

LAMINAR AIR FLOW

LAMINAR AIR FLOW is used under aseptic conditions which,

  • Provides pure & clean air with a steady velocity to the working area.
  • Protects the products & equipments from air-borne contamination.
  • The out-flow air removes the particulate contaminants suspended by the working personnel.

STANDARDIZATION & PURITY CHECKS ARE DONE BY SOPHISTICATED PROCEDURES LIKE:

  • Microtomy
  • Alkaloidal Assays
  • Chromatographic Analysis including Gas chromatography
  • Microscopy
  • Calorimetric Analysis
  • Ultraviolet Spectrophotometers

QUALITY CONTROL LABORATORY

We have developed an in-house quality control laboratory and microbiology laboratories that are equipped with chemical instruments and other instruments for conducting various quality tests on our range of pharmaceutical products. In order to keep track of all activities, parameters & processes for attaining quality comprehensively, we apply TQM techniques and follow fully autonomous functionality.

The laboratory is equipped with all the basic equipment for physico-chemical analysis, extraction, chemical analysis and assay of chemical compounds by volumetric, gravimetric, spectrophotometric, GLC & TLC techniques. Thin layer chromatography facilities for finger printing of the herbal medicine or the marker compounds are available for confirming the identity and authenticity of the medicine.

The General methods of tests conducted by our quality department for raw materials- herbs & chemicals as well as finished products of drugs and pharmaceuticals include Physicochemical and Microbiological tests.


Microbiological Tests

We have a full-fledged Microbiological Laboratory, equipped with the ultramodern equipments that conducts routine and in-depth microbiological testing procedures in order to establish product protocols and in order to validate sterilization processes. For testing bacterial and fungal contamination of herbal material with sterile testing facilities (Laminar flow hood)a full-fledged microbiology section exists. We conduct tests to assess raw materials, as well as bulk and finished formulations. Also, there is a consistent microbiological monitoring of working procedures in process areas and microbiological analysis of products.

  • Sterility test
  • Water testing
  • Equipment cleanliness monitoring
  • Sterile area monitoring

In order to keep track of all activities, parameters & processes for attaining quality comprehensively, we apply TQM techniques and follow a fully autonomous functionality.


PREPARATION OF MOTHER TINCTURES

For homeopathic pharmaceuticals prepared from botanical origin, Monograph specifications including macroscopic identification, microscopic identification and appropriate geographic regions to collect the starting material is taken care of. The moisture content is determined using Infrared Moisture Balance. Chemical methods of evaluation cover isolation, identification, purification and characteristic determination of drugs having active principles.

The final product is then tested as regards its colour, odour, pH, total solids and alcohol content to meet the required specifications. The mother tinctures thus prepared are then subjected to Thin Layer Chromatography and UV Spectrophotometry to determine their quality compliance on basis of defined parameters.

Once manufactured to Pharmacopoeial standards, the tincture is stored in neutral glass bottles in a temperature- controlled environment protected from light.


PREPARATION OF DILUTIONS

All dilutions are made from chemicals of pharma grade quality available in India and few rare chemicals are imported and are freshly prepared & potencies raised by Bakson. All dilutions made from available Mother Tinctures in our catalogue are exclusively made at Bakson.

The lowest back potency for medicines of origin like Sarcodes, Nosodes or those herbs/chemicals not made available in India, are imported. All subsequent back potencies of those are made at Bakson.

Keeping abreast with the latest & high-precision technology, Bakson has incorporated the use of 'Automatic Potentizer' to ensure standardized dynamisation of higher potencies with digital control.


TABLET SECTION

Pharmacopoeial grade, high class HMS lactose imported from Holland is used for all our tablet preparations which is stored in a dehumidified area. In the tablet-pressing process, all ingredients taken are dry, powdered and of uniform grain size as much as possible. It is ensured that the appropriate amount of active ingredient is equal in each tablet so ingredients are well-mixed. Compressed tablets are exerted to great pressure in order to compact the material. The tablets are then subjected to tests for Ash Value, Disintegration time, Hardness, Friablity besides microbiological testing before being packed. They are then bottle packed or blister packed through fully automated machines.

Triturate tablets dissolve almost instantly in the saliva of the mouth, facilitating sublingual absorption.


EYE DROPS

Some of the highlights of our manufacturing facilities of eye drops include:

  • Dispensing of materials under an SS reverse laminar flow.
  • Individual cabins with separate air handling units to avoid cross contamination in addition to air conditioning with 3 micron filtration to ensure absolute product purity.
  • Separate double skin AHU's for washing, sterilization, buffer zone and airlocks, filling areas confirming to class D, C, B & A.
  • Laminar airflow benches are designed to Class 100 cleanliness as per -ISO 5 for particle sizes 0.5 µm.
  • State of art of manufacture, filling / sealing operation.
  • Visual inspection with semi automatic inspection of machines
  • Demineralization Plant, WFI plant and SS 316L pipeline in loop form with a 5 micron filter and UV lamp for absolute purity of water.

COSMETICS

At Bakson, manufacturing of creams is taken up with the help of homogenizers and planetary mixers, through fully automatic plant without any hand touch and the same transferred through pipes directly to filling machines.

For Hair Oil and Shampoos necessary ingredients like oil or surfactants and conditioners are mixed with homoeopathic extracts through a stirrer in a mixing tank and then filtered. They are then subjected to extensive testing before marketing


PACKAGING

All products are packed to preserve their medicinal powers for long & also have a tamper-proof seal. The effective dropper mechanism permits easy delivery and prevents wastage of medicine.


ASSURED QUALITY SPECIFICATION COMPLIANCE

  • We maintain written specifications that describe the homeopathic medicine and the required test methods for specifications pertaining to identity, purity, quantity, potency and tolerances .
  • Follow conventional testing protocols for each dosage form
  • The finished product specifications control the organoleptic and physical characteristics of the product.
  • All packaging materials, such as bottles and other materials are stored properly. All containers and closures are thoroughly cleaned and dried before being used to pack the products.
  • There are adequate information on the label (or the package insert) to inform the users of the composition of the product, indications, directions for use, cautions and adverse reactions if any, and the expiry date.

We strictly adhere to GLP criteria like:

  • Test method reliability: validation and control
  • Instrument calibration and maintenance programs
  • Reagent and standard quality control
  • Authorised materials and product specifications
  • Quality, integrity and authenticity of data

Finished Product Auditing

Once a product has been produced, each lot is statistically sampled and finally the product is audited by Quality assurance inspectors for bulk weight, Liquid volume bottle count, Bottle sealing and legible lot number samples are then given to QA labs so that scientists can complete testing according to finished product specifications.


Complaints

The person responsible for handling complaints and deciding on the measures to be taken to deal with them have appropriate training and/or experience in the specific features of the quality control of herbal medicines and the records are available for inspection.


Self-inspection Training

  • The personnel have adequate training in appropriate fields such as pharmaceutical technology, taxonomic botany,phytochemistry, pharmacognosy, hygiene, microbiology and related subjects (such as traditional use of herbal medicines).
  • Training records are maintained and periodic assessments of the effectiveness of training programmes are made.
Copyright © Bakson Group 2015