The document is an industrial training report submitted by Ghanshyam for the Bachelor of Pharmacy degree, detailing his one-month internship at Roseate Medicare. It outlines the training objectives, methodologies, and various sections of the manufacturing and testing processes of pharmaceutical products at the company. The report also acknowledges the support received from supervisors and details the capabilities and certifications of Roseate Medicare as a leading pharmaceutical manufacturer. More Related Content Similar to FINAL INDUSTRIAL TRAINING REPORT Recently uploaded FINAL INDUSTRIAL TRAINING REPORT 1. INDUSTRIAL TRAINING REPORT AT Submitted for Partial Fulfillment for the Requirements for the Degree of BACHELOR OF PHARMACY By GHANSHYAM (20013614011) Under the supervision of Dr. (Prof.) RITU SANWAL SHANTI NIKETAN COLLEGE OF PHARMACY Malther (Ratti, Ner Chowk), Himachal Pradesh 175008 Approved by PCI, Affiliated to HP Technical University, Hamirpur-177071 2. I DECLARATION I “GHANSHYAM” hereby declare that I have undertaken one months Industrial Training at “ROSEATE MEDICARE” during a period from 27 JULY 2023 to 26 AUG 2023 in partial fulfillment of requirements for the award of degree of B.PHARMACY at SHANTI NIKETAN COLLEGE OF PHARMACY. The work which is being presented in the training report submitted to Department of pharmacy at SHANTI NIKETAN COLLEGE OF PHARMACY is an authentic record of training work. Signature of the Student 3. II ACKNOWLEDGEMENT First I would like to thank MR PAWAN KUMAR, HR, Head, of ROSEATE MEDICARE for giving me the opportunity to do an internship within the organization. I also would like all the people that worked along with me ROSEATE MEDICARE with their patience and openness they created an enjoyable working environment. It is indeed with a great sense of pleasure and immense sense of gratitude that I acknowledge the help of these individuals. I am highly indebted to Director DR. SURESH KUMAR THAKUR and Principal DR. VICHITRA KAUSHIK for the facilities provided to accomplish this internship. I would like to thank my Head of the Department of Pharmaceutical Industry MR NAMDEO for his constructive criticism throughout my internship. I am extremely great full to my department staff members and friends who helped me in successful completion of this internship. GHANSHYAM (20013614011) B.PHARMACY 4. III CERTIFICATE 5. IV ABSTRACT Industrial training is an important phase of a student life. A well planned, properly executed and evaluated industrial training helps a lot in developing a professional attitude. It develop an awareness of industrial approach to problem solving, based on a broad understanding of process and mode of operation of organization. The aim and motivation of this industrial training is to receive discipline, skills, teamwork and technical knowledge through a proper training environment, which will help me, as a student in the field of Pharmacy , to develop a responsiveness of the self-disciplinary nature. 6. CONTENTS SR.NO TITLE PAGE NO 1 DECLARATION I 2 ACKNOWLEDGEMENT II 3 CERTIFICATE III 4 ABSTRACT IV 5 INTRODUCTION 1-2 6 MANUFACTURING SECTION 3-8 7 PACKAGING SECTION 9-11 8 TESTING SECTION 12-16 9 CONCLUSION 17 7. 1 Shanti Niketan College of Pharmacy INTRODUCTION Roseate Medicare is a leading drug, Nutraceutical & Ayurvedic Formulation Manufacturer based out of solan hp. At Roseate Medicare we work to achieve a greater India through a healthier India. Our vision inspires us and motivates our work force to offer our clients the best post purchase experience in the industry. We pride ourselves in understanding the needs of the customers and patients and have hence developed a culture beneficial to each party involved. Our manufacturing practices exemplify the best of the industry and our promise of quality products and customer service stands firm since the company’s inception. We are also proud to call ourselves.A‘one stop shop for all oral therapeutics. Our unit is equipped with ultra-modern machinery as per WHO GMP norm. Our in-house well-equipped laboratory ensures stringent quality checks at each level of production. Our manufacturing facility is WHO, ISO 9001, ISO 22000, HACCP, GLP, GMP, & HALAL certified. VISION AND MISSION Under the visionary leadership of Managing Partner Mr. Ajay Sood, an industry expert and management specialist, the company aims to become the foremost healthcare provider in the entire Northern region of India. Our company also understands its responsibility towards the society and has undertaken several projects under the leadership of Managing Partner Mrs. Rashim Dhar Sood. One noteworthy accomplishment is its focus on empowering women through employment. The company hence boasts a majority women employment and employment of special people. 8. 2 Shanti Niketan College of Pharmacy Roseate Medicare currently manufactures over 3500 brands for over 300 clients across India. We see ourselves as a 'One Stop Shop. We offer our clients a choice of over 300 formulations in tablet, capsule, syrup, and dry powder dosage. We also offer new molecules. Over the last decade, we have established our speciality in Beta-Lactam, Cephalosporin, Neuro Psychiatry and Narcotic products. PRODUCTS MANUFACTURED 1. Rosiron 2. Rofenac 3. Rosepep 4. Rosecal-D3 5. Roserab-L 6. Rosepod-CV 7. Roseplex 8. Rosemycin 9. Kymex FIG. No-01 FIG. No-02 10. Dimet-G2 11. Rosccold 12. Roseclat-625 13. Cefscor-CV 14. Rosegesic-SP 15. Rosecold-EX FIG. No-03 FIG. No-04 16. Yprox 17. Zenolid 18. Ceficon-CV 19. Merix 20. Relevit 9. 3 Shanti Niketan College of Pharmacy MANUFACTURING SECTION Pharmaceutical manufacturing is the process of industrial scale synthesis of pharmaceutical drug by pharmaceutical companies. The process can be broken down into a series of unit operations such as milling, drying, compression, and coating. The primary goals of manufacturing section includes :- 1. To formulate tablets that are strong and hard to withstand mechanical shock encountered during manufacturing, packing, shipping, dispensing and use. 2. To formulate tablets that are uniform in weight and in drug content. iii. To formulate tablets that are bioavailable according to indication requirements. 3. To formulate tablets that are chemically and physically stable over a long period of time. 4. To formulate tablets that have elegant product identity which is free from any tablet defects. The manufacturing section have different sub division and these are as described below: A. Granulation Section B. Blending Section C. Compression Section D. Coating Section A. Granulation Section Granulation is a process of collecting particles together by creating bonds between them and these bonds are formed by compression or by using a binding agent.A process whereby small particles gathered into large, permanent masses in which the original particles can still be identified. Granulation process will improve flow and compression, characteristics, reduce segregation, improve content uniformity, and eliminate excessive amounts of fine particles. The results will be improved yields, reduced tablet defects, increased productivity, and reduced down time. The equipment’s used in the process of Granulation are :- I. Mass mixer II. Tray Dryer III. FBD (Fluidized Bed Drier) IV. Multi-mill V. Roll Compactor

10. 4 Shanti Niketan College of Pharmacy I) Mass mixer Mass Mixer is designed to perform smooth operations for thorough mixing equipped with safety transparent dust cover & specially designed self-adjusting sealing arrangement, which ensures the restriction of black particles enter the mixing drum. Mass Mixer is Ideal for dry & wet uniform mixing of materials. Mass Mixer is available in sizes ranging from 5 Kg to 300 Kg as per GMP & cGMP models. FIG. No-05 MASS MIXER II) Tray Dryer A dryer used for drying of the wet products like crude drugs, chemicals, powders or the granules, etc. is known as Tray dryer. The material which we want to dry is dispersed on the tiers of the trays. The tray. which is used in this process must have perforated, solid or wire mesh bottoms. For the circulation of the air across the drying materials, we lined the screen trays with paper. A limited amount of heat is provided to every shelf at that time when the wind passes over it to provide the latent heat of vaporization. This kind of dryers provides proper control of humidity and temperature. FIG. No-06 TRAY DRYER 11. 5 Shanti Niketan College of Pharmacy III) FBD (Fluidized Bed Dryer) Fluidized (fluid) bed dryers are used extensively in the pharmaceutical industries to reduce moisture content of pharmaceutical powder and granules. They have also found use in the drying of suspension, slurries, solutions, dilute paste or sludges. A typical fluidized bed dryer consists of the following components. Air preparatory unit. 1. Product container. 2. Exhaust filter. 3. Exhaust blower. 4. Control panel. 5. Air distribution plate. Spray nozzle. 6. Solution deliver. In fluidized bed dryer, hot air is passed at high pressure through a perforated bottom of the container containing the wet solids. The wet solids are lifted from the bottom and suspended in a stream of air (fluidized state). The hot air then surrounds every granules. Heat transfer is accomplished by direct contact between the wet solid and hot gases. The vaporized liquid is carried away by the drying gasses FIG. No-07 FLUIDIZED BED DRYER 12. 6 Shanti Niketan College of Pharmacy IV) Multi-mill Multi Mill is used in different functions involving wet & dry granulation pulvenisation etc. of Pharmaceutical, Chemical, Bulk drug. Cosmetic, Colors. Food products etc. The Industrial Multi Mill consists of stainless steel hopper, processing chamber with beater assembly, Motor, DOL stater, three speed pulley, screen and study body. FIG. No-08 MULTI-MILL V) Roller Compactors Roller compactor are used to force fine powders between two counter rotating rolls and presses the raw materials into a solid compact (flakes, sheets, strips). Roll Compacters are also called dry granulators. Principle:- A roller compactor generally consists of three major units. 1) A feeding system, which converts the powder to the compaction area between the rolls. 2) A compaction unit, where powder is compacted between two counter rotating rolls to a ribbon by applying a force. 3) A size reduction unit, for milling the ribbons to the desired particle size FIG. No-08 ROLLER COMPACTOR 13. 7 Shanti Niketan College of Pharmacy B. Blending Section Blending is a process which mixes the API and excipients to ensure there is a homogeneous mixture of the all ingredients for each manufacturing process. Blending is a process that can be carried out numerous times within a manufacturing process when new excipients need to be added. Blending is carried out by the help of Blender, FIG. No-09 OCTAGONAL BLENDER C. Compression Section Tablet compression machine makes the tablets by pressing the granules in die with lower and upper punch. Different innovations to tablet compression machines are being done to improve the production rates and now it is possible to produce more than 500,000 tablets per hour. A tablet formation takes place by the combined pressing action of two punches and a die. The basic principle behind the tablet compression machine is hydraulic pressure. This pressure is transmitted unreduced through the static fluid. Any externally applied pressure is transmitted via static fluid to all the directions in the same proportion. It also makes it possible to multiply the force as needed. FIG. No-10 DOUBLE ROTARY COMPRESSION MACHINE 14. 8 Shanti Niketan College of Pharmacy D. Coating Section Coating is a process by which an essentially dry, outer layer of coating material is applied to the surface of a dosage form in order to confer specific benefits over uncoate variety. Coating may be applied to a wide range of oral solid dosage form, such as particles, powders granules, crystals, pellets and tablets. When coating composition is applied to a batch of tablets in a coating pan, the tablet surfaces become covered with a tacky polymeric film. FIG. No-11 COATING MACHINE 15. 9 Shanti Niketan College of Pharmacy PACKAGING SECTION Packaging is defined as the collection of different components which surround the pharmaceutical product from the time of production until its use. Importance of packaging 1. Protect against all adverse external influences that can alter the properties product. Protect against biological contamination. 2. Protect against physical damage. Carry the correct information and identification of the product. Tamper evident/Child resistance/Anti counterfeiting. There are mostly three types of packaging are used and these are as follows:- A. ALU-ALU Packing B. Blister Packing C. Strip Packing A. ALU-ALU Packing Ideal for products that need packaging between two sheets of aluminium foil, such as candies, foodstuff, tablets and pills. The equipment is able to operate without light, and therefore meets the requirement for sensitive products that are cannot tolerate exposure to light. Can also be used for plastic to plastic sealing. Ideal for aluminium to aluminium foil heat sealed packaging of products The machine automatically completes functions such as cutting margin scrap, broken piece filtering, and material feeding. Batch number printing can be automated, and even transverse impressing. It is fully programmable via a programmable logic controller (PLC). Can enhance the presentation of the product item and extend its durability. FIG. No-12 ALU-ALU PACKING MACHINE 16. 10 Shanti Niketan College of Pharmacy B. Blister Packing This machine is ideal for packaging pharmaceutical materials in blister packs that use materials such as polyvinyl chloride, polystyrene and polypropylene. 1. The vibration feeder and crisp remover can remove the powder and crisps inside medicine effectively. 2. Horizontal perforation. 3. Auto-counting slitting waster-side cutting. 4. Automatically prints batch number. 5. The diameter of the heat pressing cam can be modify from 110 to 140mm. The working principle of the flat blister packaging machine: the formed film is heated and softened by the flat heating device, and the softened film is blown into a blister by using compressed air in the flat forming device, and the filling device fills the package into the blister FIG. No-13 BLISTER PACKING MACHINE 17. 11 Shanti Niketan College of Pharmacy C. Strip Packing A high-speed machine that is ideal for different products such as tablets or capsules. Machines are robust and well constructed and generally provide high quality by using accurate temperature control, and the ability to exert variable pressure on the sealing rollers. A strip packaging machine is ideal for coating heat sealable films such as polymer-coated aluminium foil, and polymer-coated paper. Important features of the machine are: Availability of Standard interchangeable parts Cutting arrangement are adjustable 1. Quick and easy change of parts for application with different product types 2. Precise knurling (sealing rollers) Smooth, silent operation The Products from the hopper passes through a stainless steel feeding system and goes to sealing roller cavities where laminated foils, drawn from two rollers, packs and seals the products in a continuous strip FIG. No-14 STRIP PACKING MACHINE 18. 12 Shanti Niketan College of Pharmacy TESTING SECTION Tablets should be subjected to a number of tests before they are deemed fit for marketing and consumption. The tests that are performed during manufacturing process are as follows:- a. Shape and Size of Tablets b. Weight Variation Test c. Friability Test d. Hardness Test e. Disintegration Test f. Dissolution Test a. Shape and Size of Tablets It can be dimensionally described monitoring and checked visually the tablet shape is Round, Elongated, Triangular, Oval, etc. 1. Tablet diameter and thickness can be measured by Vernier Caliper. 2. Tablet thickness should be controlled within a range of ± 5%. There are a variety of different sizes of pharmaceutical tablets available, but most tablets range from 1 mm to 22 mm. There are different sizes of pharmaceutical tablets available on the market to help support the end-user. Typically, standard-sized tablets are about >5 mm in diameter. FIG. No-12 19. 13 Shanti Niketan College of Pharmacy b. Weight Variation Test Weigh individually 20 units selected at random and calculate the average weight. Not more than two of the individual weights deviates from the average weight by more than the percentage given in the pharmacopeia and none deviates by more than twice that percentage. c. Friability Test Friability testing is a method, which is employed to determine physical strength of uncoated tablets upon exposure to mechanical shock and attrition. In this test 20 tablets are used, the rotation is 25 RPM per minutes and is done for 4 minutes. The tablets fall down from 6 inches height. The % weight loss should not be more than 1%. Percentage Friability = W1-W2/W1 x 100 Where, W1 = weight of tablets before testing W2= weight of tablets after testing FIG. No-13 FRIABILITY TEST APPARATUS 20. 14 Shanti Niketan College of Pharmacy d. Hardness Test Tablet hardness testing is a kind of laboratory technique, which is employed to test breaking point of a tablet. For pharmaceutical units this process is an important part of medicine production that ensures tablets must be hard enough to withstand mechanical stress during various conditions such as storage and packaging, transportation and handling by the consumer etc.There are two types of Hardness Tester:- i. Monsanto Hardness Tester ii. Pfizer Hardness Tester FIG. No-14 MONSANTO HARDNESS TESTER FIG. No-15 PFIZER HARDNESS TESTER 21. 15 Shanti Niketan College of Pharmacy e. Disintegration Test Disintegration test is performed to find out that in how much time the tablet disintegrate.Sieves size used in Disintegration test apparatus is 10 no. And up & down rotation is 28-32 cycles per minutes at a height of 5-6 cm. The temperature of liquid medium is 37°C. Disintegration Time for tablets as per IP, BP and USP Disintegration Time:- i. Uncoated Tablet NMT 15 min, in water with Disc 37°C ± 2°C ii. Coated Tablet NMT 30 min, In water with Disc for Film Coated Tab, and NMT 60 min Other than Film coated table iii. Enteric Coated Tablet Intact for 2 hr in 0.1 N HCI & disintegrate within 1 hr in Mixed 6.8 Phosphate buffer. FIG. No-16 DISINTEGRATION TEST APPARATUS 22. 16 Shanti Niketan College of Pharmacy f. Dissolution Test Adissolution test is a means of identifying and proving the availability of active pharmaceutical ingredient (API) in their delivered form. A dissolution test reflect the availability of active substance and allows the prediction of the time for complete release of the material from the dosage form. There are many kinds of dosage forms of course and all of them have a dissolution rate. The dissolution time can range from seconds to hours or even days for implants according to IP, BP & USP to the specified drugs. Dissolution is the process by which a solid substance enters into a solvent to form a solution. Pharmaceutical definition: Dissolution is a test used throughout the life cycle of a pharmaceutical product to evaluate the rate of release of a drug substance from the dosage form. FIG. No-17 DISSOLUTION TEST APPARATUS 23. 17 Shanti Niketan College of Pharmacy CONCLUSION During Industrial training period, a lot of experience, knowledge and exposure that I have handy. All disclosures were awaken myself in a boost of self-confidence to face life more challenging now. Practical is a complement to the science or theory learned. This is clearly the concept of science and charity, where they have learned without practice will be lost and will not give anything. During my industrial training, there are many changes from the point of learning environments and discussion among colleagues. It can directly increase the dedication and rational attitude toward myself. However, there are still some weaknesses that can be improved in the future. Therefore I conclude that the industrial training program has provided many benefits to students even if there are minor flaws that are somewhat disfiguring condition, so that this weakness can be rectified in the future. I can conclude that this industry is through training I received a lot of exposure in the Pharmacy world. I would like to thank all student for find their own experience with having Industrial Training like this.