Manufacturing Facilities, Technologies and Equipment’s
Tablets
Tablets are the major product ranges in OSD (Oral Solid Dosage) production facilities comprising about 45% of the total pharma production. To fulfill the market demand a new compliance area has been developed where many sophisticated machines like Auto-granulation line, Fette Tablet Compression machine from Germany, Sejong Tablet Compression machine from South Korea, Romaco Compactor for potent and sensitive drugs have been incorporated in this area.
Moreover, we have another two dedicated granulation units (one is Auto-granulation), six sophisticated tablet compression machines, six tablet coating machines including IMA tablet coating (from Italy) which is highly sophisticated and faster, eight blister machines including Heino-Ilsemann blister machines (from Germany) with auto-cartooning, Romaco blister machine (from Germany) with auto-cartooning and 21CFR part11. Besides we have two Auto tablet counting machines.
Capsule
Two sophisticated automatic capsule-filling machines Pam from India and NJP from China are now in operation. These machines have a versatile capacity for filling pellets and liquids in hard gelatin shells. Two existing automatic Zanasi Capsule filling Machines are used for non-antibiotic & miscellaneous antibiotic production.
In view of the increased demand for existing powder fill capsule products & considering the upcoming new products to our product range, the IPI management has installed a high-capacity powder capsule filling machine recently. This machine can also be used for pellet filling. Now we are fulfilling the present demand by blistering with the Hoonga blister machine from Korea and the newly installed high-capacity Tien Tuan blister machine from Vietnam.
Ophthalmic
Ophthalmic Products are marketed under the division named "Sinavision". These include ophthalmic drops, ointment and gels. All the ophthalmic products are manufactured in class A under HVAC system in a background class B. We have installed a fully automatic ophthalmic eye drops production line including automatic washing, drying, autoclaving, filling and sealing. A fully automatic eye drops filling machine Idositechno from Spain (under installation) and an automatic lamitube filling machine from China has been installed.
Injectable (Parenteral)
The injection production facilities comprise Class A (ISO Class 5) production area and the adjacent areas are of different classification and there is a change room facilities as per compliance. The sterile products are manufactured in high-tech machines like Rota (Germany) and Flexicon (Denmark). IPI is launching Prefilled Syringes, Lyophilized Vials, Small Volume Parenteral (SVP), Biotech preparations to its product portfolio by dedicated sophisticated machines like Lyophilizer (Freeze Dryer) (Tofflon, China), Solution Preparation Vessel and CIP & SIP Skid (Tofflon, China), Automatic Prefilled Syringe Filling & Sealing Machine (iDOSETECHNO, Spain), Flexicon Dry Powder Filling Machine (Denmark), Freeze Drying Microscope (FDM) (McCRONE, USA), Fedegari Autoclave (Italy) and Vaporized Hydrogen Peroxide (VHP) Sterilizer (China). Some Injectable productions including Esolok 40mg Injection, Prolok 40mg Injection, Pantolok 40mg Injection and Oxyfer Injection already in the market.
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI)
A dry powder inhaler (DPI) is a breath-actuated device that delivers the drug in the form of particles contained in a capsule or blister that is punctured prior to use. This type of inhaler requires an adequate inspiratory flow rate for drug delivery, as it does not include a propellant. Dry powder inhalation (DPI) capsules are a type of pharmaceutical dosage form designed for the delivery of dry powder medications to the respiratory system, primarily for the treatment of respiratory diseases such as asthma or chronic obstructive pulmonary disease (COPD). These capsules are intended for use with inhalation devices, commonly known as dry powder inhalers (DPIs).
A metered-dose inhaler (MDI) is a device that delivers a specific amount of medication to the lungs in the form of a short burst of aerosolized medicine that is usually self-administered by the patient via inhalation. It is the most commonly used delivery system for treating asthma, chronic obstructive pulmonary disease (COPD) and other respiratory diseases. The medication in a metered dose inhaler is most commonly a bronchodilator, corticosteroid or a combination of both for treating asthma and COPD. Other medications less commonly used but also administered by MDI are mast cell stabilizers, such as cromoglicate or nedocromil.
Semisolid Products
Some popular brands of topical ointments, creams and gels are produced in the IBN SINA Pharma factory. These products are manufactured with an automatic Italian Axomatic Lamitube Filling Machine that's online with an emulsifier. Products are Fungicort cream, Fungin cream, Fungin-B cream & Neocort ointment etc. In every year new products are added with existing products.
Liquid Products
The IBN SINA Pharmaceutical Industry PLC is one of the leading manufacturers of liquid pharma products in Bangladesh. It has five production lines including (1) Auto-Glass Bottle Line for Syrups, (2) Auto-Antanil Production Line, (3) High Capacity PET Line for Syrup and Suspension Products, (4) the Pediatric Drops & Suspension Line, and (5) High Capacity PET Bottle (Vitalgin) filling line.
Auto PET Bottles and other Liquid Production Lines are the most sophisticated liquid production lines. There is a bottle feeding unit, rotary bottle washing unit, light checking unit, multi-head linear liquid filling unit, capping & sealing unit, auto sticker labeling unit and packing line with auto carton strapping unit. It has a production capacity of 120-150 bottles per minute. A dedicated & compliance online Gavisol Suspension process & filling line is under construction. Powder for Oral Suspension Products Powder for suspensions are mainly antibiotic products intended for children and young patients. We have two separate areas for the production of power for suspensions. The major powder for suspension brands are Bactin, Nitasol, Erymex, Romycin, Buticef, Iluca etc. Sachet Unisaline is a popular brand of IBN SINA for ORS. We have a self-contained separate production facility for sachets, lined with three sophisticated sachet-filling machines. IBN SINA Pharma has already started marketing Unisaline with different flavors like Fruity Lemon, Fruity Orange & Fruity Mango. Many new products including Tasty & Rise ORS are in the pipeline. Another non-ORS sachet brand is Sinalax, which was introduced in Bangladesh by IBN SINA Pharma for the first time.
Cephalosporin Division
State of the Art Cephalosporin Product Manufacturing Plant
In the year of 2011 the management of The IBN SINA took a noble step to build a dedicated plant for manufacturing of Cephalosporin products and in 2016 build state of-the-art manufacturing unit named as Cephalosporin Division.
This state of-the-art Cephalosporin product manufacturing facility is a three storied building having 17,500 sft/floor, equipped for the manufacturing of tablet, capsule, powder for suspension and dry powder for injection with the latest technology and has a team of qualified and experienced personnel to run the plant. After starting its manufacturing activities in 2017 this plant goes through continuous expansion & up gradation. It is now equipped with highly sophisticated and advanced facilities. The facility is planned and designed to meet the local as well as international demand both qualitatively and quantitatively.
It is our pride to mention that we have been manufacturing cephalosporin drug products in a self contained dedicated and cGMP complaint plant which has enabled us to meet the international compliance requirement. The plant was constructed under the direct guidance and consultancy of APC Australia with the aim to GMP accreditation from TGA Australia. Zone concept of Current Good Manufacturing Practice (cGMP) is meticulously implemented in the site. Qualification, Operation and Documentation are as per cGMP requirement. Quality System and Environment, Health & Safety (EHS) system has been implemented in the site as per TGA requirements.
This plant is equipped with world class HVAC systems. All manufacturing machineries are digitally programmed for highest precision. The production process provides an absolute sterile manufacturing condition for injectable products, which is ensured through a series of fully automated manufacturing procedures and machines from world’s premium pharmaceutical equipment manufacturers like; Romaco Macofar (Italy), Zirbus (Germany), CVC (Taiwan), Sejong (South Korea), N.R. (Thailand).
It is a wide ranging concept covering all matters that individually or collectively influence the quality of a product. For that purpose, a skilful, well trained and experienced bunch of persons engaged in QA department are responsible for evolving, implementing and monitoring quality assurance activities having an impact on product quality. QA department has four (04) major sections like Documentation, Compliance & Training, IPQC and Validation.
A modern and well equipped QC laboratory and Microbiology laboratory have been set up at the first floor of cephalosporin division. It ensures quality, safety, purity & efficacy of starting material and finished product before release for sale. The Microbiology lab includes Grade A/Grade-B clean room with adequate differential pressure adjustment facilities.
Pharmaceutical Product Development is a challenging venture for local & global markets and the development of novel drugs. Our PD team emphasize on successfully developing & introducing quality products according to guidelines and continuous improvement of new and existing product for customer satisfaction, environmental change, technology change, and other competitors. We are constantly pumping new products into the market that helps the company to survive and build up its image.
Good Engineering Practices (GEP) ensures periodic preventive or breakdown maintenance for facility, machines and equipment all are in place to ensure cGMP compliance and quality products.
Warehouse of raw materials, packaging materials as well as finished products meet with the compliance of cGMP requirement. There are well racking and quick tracing systems and all the inventory is controlled through ERP. Sampling booth and cold storage (2-8) °C are also available inside the warehouse.
Environmental and compliant issues in the production of cephalosporin medicines stand first. We are fully committed to achieving excellence in Environment, Health, and safety (EHS) and conduct our activities in the most responsible manner. The importance of EHS is continually stressed and extensively promoted as a part of our corporate culture. The key processes comprise regular safety surveillance, inspections, and audits, operation of the Effluent Treatment Plant (ETP)/Incinerator; disposal activities related to hazardous wastes; and regular monitoring of the environment, internally and also through approved laboratories. We accord the highest priority to hygiene monitoring at the workplace and health assessment of all employees at facilities. Our plant and processes are continuously upgraded to improve hygiene and health standards. Necessary training is imparted to employees to enhance their awareness of health and safety-related matters.
We know where we are now and we have clear vision about where & how we want to go. That’s why to meet the future challenges of globalization we built one of the finest pharmaceutical plants of the present time as per the cGMP guidelines of TGA. Quality is our prime concern. We believe that quality does not end; it’s a sustained process that we continuously try to develop.
Fire, Water & Air Management System
Fire Management System
IPI uses an intelligent addressable fire detection system. Fire drills are done at least two in every year and training is provided to the personal who are members of the fire team. Our actions in this context are: We have adequate training facilities against fire, earthquake and other disasters. Almost all employees were trained in fire defense by the Bangladesh Fire Service and Civil Defense.
Health & Safety Consideration
Our Plant has been designed following the modern concept of safety guidelines. We make regular safety assessments and ensure compliance with all existing laws in the field of environmental protection, hygiene and safety at work. A special care and training are planned for the safe handling of Hazardous chemicals. A Standard Operating Procedure (SOP) on safety guidelines is followed by each and every person in our Plant.
Water management system
Pure water is very essential and inevitable element for every Pharmaceutical Industry. IPI is committed and constantly working on improving the water management of the company and plant as conserving water will contribute to more sustainable water availability.
Our actions in this context are:
We have the most modern RO (Reverse Osmosis) Plant with 3000 lit/hr capacity for fulfilling our present water demand. We have another most modern DM (Demineralization) Plant with 3000 Ltr/hr capacity for fulfilling our present water demand. Air management system IPI has the right air management technology installed in all buildings as pharmaceutical manufacturing facilities require high-quality air because the products are ingested or placed in humans and animals.
Our actions in this context are:
We have an individual Air Handing Unit (AHU) with HEPA filter. All the areas including Production, QA, QC, PD, Microbiology, Warehouse and other utility areas are covered by smoke detectors and modern fire alarm systems. The whole facility is equipped with an adequate number of fire extinguishers and fire hoses with a fire hydrant. We also have a proper evacuation system and an assembly point with a dedicated rescue and first aid team. High-pressure fire pumps along with standby pumps and jokey pumps are installed to fight against fire.
We have a precise temperature control system. We have a precise humidity control system. We have a precise pressure difference control system by software. Environment, Health and Safety Consideration The inherent safety risks relating to the pharmaceutical and chemical industry will always be a key focus as standardized health, safety and environment (HSE) processes are embedded across all of our operations. The IBN SINA Pharmaceutical Industry PLC is committed to pursuing excellence in Health, Safety and Environment and conducts its activities safety and in an environmentally responsible manner. Safety is our priority. It is integral to our culture. In order to ensure reliable and safe operations, we continue to focus on the day-to-day management of operational risks, including risks related to Health, Safety and the Environment. To promote safety throughout the business operations, execute management meets regularly to review the environment and safety performance.
It is the nature of our industry that our people face many stressful situations in the workplace. We continue to offer comprehensive health and wellness services to our employees. Our employees' Physical and emotional well-being appears to be in line with the industry norms related to Health, Safety and Environment.
Environment Consideration IPI gives utmost importance to environmental protection and strictly avoids activities that may have any adverse impact on the environment. We believe that environmental protection should be implemented due to climate changes and natural calamities that affect our country every year. We have therefore designed the production process in the most resource and energy -and energy-efficient way possible.
Our actions in this context are:
We have established an Effluent Treatment Plant (ETP) capacity of 500 liters/hr. to treat effluent from plants. We are conducting incineration by Prism Bangladesh Foundation.
Our Steps
Our Steps to Health, Safety and Environment our steps to health, safety and environment. We have a specialized medical team in our plant premises for employees' health-related issues.
For COVID-19 and other related issues, we always concern about our employee's health and safety. We arrange COVID-19 vaccines for our employees and strictly follow the safety rules. Our all areas are well furnished with modern fire alarm systems, an adequate number of fire extinguishers, fire hoses with fire hydrants and other fire safety equipment. We have a well-trained firefighter team and an adequate training system. We have a central Effluent Treatment Plant (ETP) capacity of 500 lit/hr. to treat effluent from plants.
We send all of our hazardous pharmaceutical products to Prism Bangladesh Foundation for incineration by double chamber incinerator maintaining 1100 temperature at the Medical Waste Management Plant.