PowerPoint Presentation

[Virtual Presenter] Hello and welcome to S-S-F Plastics (India) pvt. ltd. innovation week initiative 2024. Today we will be discussing Polymer Vials a type of packaging for liquid medications designed to provide the best properties of both plastic and glass materials. They are highly valued in the pharmaceutical industry and are expected to expand in terms of market growth over the coming years. The convenience and versatility of these vials have made them increasingly popular among consumers and have led to their use in flexible aseptic filling applications. In this presentation we will explore the various aspects of Polymer Vials and how they can benefit the pharmaceutical industry..

[Audio] We will discuss the topic of polymer vials today. Polymer vials are a combination of plastic and glass packaging that offer the best of both worlds. They have a single-layer structure based on Polypropylene (P-P---) Cyclic Olefin Polymer (C-O-P--) or Cyclic Olefin Copolymer (C-O-C--). Polymer vials have an inert contact surface making them ideal for use in various pharmaceutical applications and provide a unique packaging safety feature to manufacturers of biologic toxic or high potency drug solutions. Apart from monolayer C-O-P vials there are also PP H-D-P-E and multilayer PP vials options available. Polymer vials come in a range of sizes including 2 5 10 20 and 50ml. The critical dimensions of the vials such as height body diameter or neck diameter are according to ISO 8362. Polymer vials are a versatile packaging solution that offers safety convenience and durability making them a popular choice for the pharmaceutical industry..

[Audio] The global polymer vials market is projected to expand at a C-A-G-R of 4.6%. Polymer vials are widely used in pharmaceutical biopharmaceutical compound pharmacy and other places for the purpose of enhancing the shelf life of the final products. Unlike plastic or aluminum it does not impart the flavors into the drug stored thus maintaining the purity of the drug. Such trends are fueling the demand for polymer vials in the packaging of pharmaceutical and personal care products. Polymer vials not only provide safety and durability to the medicines in transportation or store but also offer a convenient user experience to the consumers. The increasing demand for ready-to-use vials for flexible aseptic filling is gaining prevalence among researchers which is driving the demand for polymer vials globally. In conclusion the polymer vials market is expected to experience significant growth in the coming years..

[Audio] S-S-F Plastics (India) pvt. ltd. offers various polymer vial options for the Innovation Week project 2024. Polypropylene (P-P---) vials are an FDA-approved plastic material commonly used for packaging human medicine. They are time and cost-efficient as they do not require a washing and drying plant. Clear plastic C-O-C or C-O-P vials meet ISO-standard 8362 and are transparent making them ideal for protecting the environment by saving water and power during production. High-density polyethylene (H-D-P-E-) vials are used in the veterinary industry and support irradiation (gamma/e-beam). They are also suitable for aseptic filling and can reduce transportation costs and storage needs. Multilayer PP vials have improved barrier properties and can protect against gases and oxidation. They are available as Ready-to-Use which is suitable for aseptic filling..

[Audio] We present innovative vials made of C-O-C or C-O-P plastic transparent alternatives to glass vials. These vials have 100% transparency are lightweight and have impact strength making them a groundbreaking packaging solution for the biotech and pharmaceutical industry. We manufacture these vials from C-O-C and C-O-P plastic completely transparent allowing us to inspect the vial fluid for particles during the production process and before use. Plastic vials are the safe solution protecting both humans and animals against harmful effects such as glass particles causing problems or contamination of the surroundings. We ensure the safety and quality of our products..

[Audio] We are developing a polymer vial alternative to the glass vial industry for the pharmaceutical industry. Our goal is to reduce costs of manufacturing polymer vials and minimize the use of natural resources during glass manufacturing. We are targeting the diluent for vaccines and inactive vaccines market with our approach. We have identified suitable polymer sources for vial manufacturing and will use I-B-M as the conversion technology. By using polymer vials we aim to eliminate harmful substances produced during glass manufacturing like silica dust heavy metals volatile organic compounds carbon monoxide carbon dioxide sulfur dioxide and nitrogen oxides. Our initiative will have a significant impact on the healthcare industry and lead to a more sustainable and eco-friendly future for all..

[Audio] We are discussing the Polymer Vials initiative and market segments. The study shows that vials fill volume in this segment ranges from 5 10 20 50 and 100 ml. We have observed that the target S-K-U size in this market segment is 50-100 ml. To start with we are focusing on the 50 ml pack size which feels in between and has the highest consumption rate among all pack sizes. We have obtained an existing 50 ml polymer vial sample from the market for our analysis. If required a rapid prototype of the same can be prepared and displayed to compare it with the market sample..

[Audio] Discussing features and necessities of Polymer Vials in pharmaceutical industry. Vials must utilize inert polymer materials for stability and safety of substance. Meet regulatory compliance by conforming to ISO-standard 8362 being pyrogen-free bacteriological endotoxin tested and having good barrier properties. Cold heat resistant 100% transparent high impact strength suitable for autoclaving and gamma-irradiation. Manufacturing facility should comply with I-S-O class 7/EU-GMP class C sterile filtered air for blowing vials and undergo quality testing every third hour. Polymer Vials are crucial in pharmaceutical industry due to safety reliability and effectiveness and are subject to strict regulations and quality standards..

[Audio] We specialize in manufacturing Polypropylene (P-P---) vials using the I-B-M manufacturing process and a suitable raw material identified as I-B-M manufacturing process as Purell RP271G. Our primary focus is on the veterinary market where we intend to introduce a PP-based vial for Live Vaccine Diluents & Dead Vaccine. These vials are already prevalent in the Indian and global market. The vaccine diluent market in India has been witnessing growth due to the increasing vaccination efforts post C-O-V-I-D pandemic and the expansion of immunization programs. With India being one of the largest vaccine producers globally and continuously expanding its vaccination initiatives the demand for vaccine diluents is expected to rise. We have procured some PP vial samples from the market benchmarked & analyzed them. We have also made 2D & 3D drawings for a 50ml vial with the help of our in-house design team. We plan to manufacture a single cavity Pilot mold and search for a potential client who will be an anchor customer in the development process with the help of our marketing team. In case the pilot mold is already available we can use the same mold for procuring initial trial samples. We have identified a suitable supplier for C-O-C vials manufacturing where we are collaborating with mitsui CHEMICALS INDIA PVT. L-T-D--. (APEL™ Cyclo Olefin Copolymer)..

[Audio] Polymer Vials by S-S-F Plastics (India) pvt. ltd. are versatile and suitable for a variety of applications. These vials can be processed using blow molding including blow-fill-seal (B-F-S--) technology ISBM and I-B-M (1-stage process) for ampoules and bottles up to a maximum of 2 liters. The melt flow rate for Purell RP271G is 1.9 g/10 min while for Random Copolymers (P-P---) it is 1.7 g/10 minutes. S-S-F Plastics (India) pvt. ltd. is also offering Bormed RB801CF as a material option for the Polymer Vials. Bormed RB801CF is a low melt flow polypropylene random copolymer resin with good clarity good impact properties high temperature resistance suitable for autoclave sterilization. It has a melt flow rate of 1.7 g/10 minutes..

[Audio] Our line of inactivated vaccines provides long-lasting immunity against virulent forms of infectious diseases. These vaccines are grown on S-P-F embryonated eggs ensuring the highest level of immunogenic inactivated viruses before inactivation. We offer a range of products including the Newcastle disease vaccine Avian infectious bronchitis disease vaccine Newcastle disease vaccine concentrated and Infectious bursal disease vaccine. To purchase our products simply click on the links provided..

[Audio] These vials are designed to enhance the immunity of birds against infectious coryza disease. Each dose in these vials contains a pre-inactivation titer of 1 x 108 C-F-U of Haemophilus paragallinarum serotypes A B & C These vials are intended for breeder hens and commercial layers. Birds should be vaccinated between 10 to 14 weeks of age and a revaccination should take place 4 to 6 weeks after the first dose. A dose of 0.5 ml per bird is recommended. It's important to note that the administration of these vials should be done subcutaneously in the lower neck region using standard aseptic techniques. It's also important to ensure that all birds in the flock are properly vaccinated but do not vaccinate within 42 days of slaughter. These vials are available in 500 ml polypropylene bottles and 18 bottles are packed per case. Each bottle contains 500 and 1000 doses of the bactarin. It's important to protect these vials from direct sunlight and store them between 20C and 80C; do not freeze them..

[Audio] Polymer vials used for storing and transporting sensitive substances can be ensured of quality and reliability through these testing methods: visual inspection dimensional analysis leak testing sterility testing chemical compatibility testing biocompatibility testing light transmission testing temperature cycling testing impact resistance testing and accelerated aging studies. Polymer vials that pass these testing methods are suitable for their intended use and provide a reliable solution for storing and transporting sensitive substances..

[Audio] We are discussing the key challenges that face when designing polymer vials for S-S-F Plastics (India) pvt. ltd. The main challenges include making the vials compatible with existing lines achieving the required level of transparency for visual inspection meeting regulatory requirements related to heavy metals migration tests and other criteria supporting sterilization by Auto-calving and Gamma-irradiation and considering scalability and cost-efficiency in the manufacturing process. To address these challenges we need to select the right grade of polymer and match the neck dimensions with glass vials to use the same existing rubber stopper and metal seals. By designing vials that meet all of these requirements we can ensure that our polymer vials are safe effective and cost-efficient..

[Audio] PP-based vials have been identified as a key component of the veterinary market. We have partnered with Victor (China) to conduct pilot studies on product compatibility and line trials with the aim of launching PP vials. We are actively identifying lead partners for specific applications in the veterinary vaccine & diluents market including HESTER & Venky’s (India). Once we have successfully launched PP vials we will explore the development of COC & C-O-P vials for specialized applications taking into account market needs..

[Audio] Our clear polymer vials are perfect for any laboratory or research facility due to their high-quality polypropylene material special neck design and leak-proof design. The vials come in sizes ranging from 30 ml to 100 ml and are priced between Rs. 3.50 and Rs. 3.90 per piece. We offer excellent value for money. Contact us for any questions..

Thank you.

[Audio] Polymer vials are essential components for storing and transporting pharmaceuticals vaccines and other sensitive substances. To ensure suitability for these applications critical requirements must be met. These requirements include material integrity chemical compatibility sterility leak resistance clarity and transparency dimensional accuracy biocompatibility resilience to temperature variations light protection scalability and cost-efficiency. By meeting these requirements polymer vials provide a reliable and safe solution for storing and transporting sensitive substances..

[Audio] Polymer vials are crucial in various fields notably pharmaceuticals. They offer several advantages over traditional glass vials including safety chemical resistance lightweight customization affordability and innovation. Polymer vials are designed to ensure the safe and efficient handling of valuable substances in industries where product integrity is paramount..

[Audio] To ensure the safety and efficacy of any product that uses these vials it is crucial to meet the following key requirements for PP/COC/COP plastic vials: The vials must be blown using sterile filtered air. They should be packed in a room that complies I-S-O class 7 / EU-GMP class C Quality testing should be conducted using test samples every third hour as a minimum and the bottles should be examined for particles. The vials should undergo bacteriological and endotoxin testing and be pyrogen-free. To meet the ISO-standard 8362 which means that it is identical to a type-I glass vial added benefit/USP: Can be delivered Ready-to-Use no wash needed before filling. These vials should also have good barrier properties and be suitable for autoclaving at 121 degrees C /250 degrees F for 15 minutes. They should come in sterile state (gamma-irradiated) and be cold & heat resistant. Additionally they should be 100% transparent enabling easy identification of fluid particles and have high impact strength. We recommend that these requirements be met in order to ensure the safety and efficacy of any product that uses these vials..

[Audio] Polymer vials typically made of materials like polyethylene terephthalate (P-E-T--) or polypropylene (P-P---) offer advantages such as flexibility impact resistance and reduced risk of breakage compared to glass. However they may have higher gas permeability and lower barrier properties than glass. Polymer vials may offer advantages such as reduced breakage during handling and transportation lightweight construction and flexibility in design. However their performance characteristics particularly in terms of barrier properties and compatibility with certain drug formulations may vary depending on the specific polymer material used. Polymer vials are increasingly being adopted in the pharmaceutical industry but their use may require additional scrutiny to ensure compliance with regulatory standards. Manufacturers must demonstrate the suitability of polymer materials for pharmaceutical packaging including compatibility with drug formulations and compliance with relevant regulations..

[Audio] We will discuss vials specifically the choice between glass and polymer vials. Vials are an important packaging solution for pharmaceuticals. In this presentation we will explore the factors that influence the choice between glass and polymer vials. Let's start with cost. Glass vials may have higher initial production costs compared to polymer vials due to the cost of raw materials and manufacturing processes. However they may offer cost advantages in terms of long-term stability reduced risk of leaching or interactions with drug formulations and recyclability. On the other hand polymer vials are often more cost-effective in terms of production costs transportation and handling due to their lightweight construction and reduced risk of breakage. However their cost-effectiveness may vary depending on factors such as material selection design complexity and regulatory requirements. Moving on to environmental impact glass vials are recyclable and can be reused multiple times making them environmentally friendly. However their production process consumes more energy and resources compared to polymer vials. Polymer vials particularly those made from recyclable materials like P-E-T or PP offer environmental benefits such as reduced energy consumption and lower carbon footprint compared to glass vials. However concerns exist regarding the recyclability and biodegradability of certain polymer materials. In summary the choice between glass and polymer vials depends on factors such as product requirements regulatory considerations cost constraints and environmental considerations. Both materials have their advantages and limitations and pharmaceutical companies must carefully evaluate these factors to determine the most suitable packaging solution for their specific needs..

[Audio] We will discuss the costing comparison between glass and polymer vials. Polymer vials are made from cheaper materials and their manufacturing processes are more efficient. Glass vials are more expensive due to higher raw material costs and more energy-intensive manufacturing processes. Polymer vials are lighter and less prone to breakage resulting in lower transportation costs. Glass vials are heavier and more fragile resulting in higher transportation costs. Overall polymer vials can be a more cost-effective solution for vial production..

[Audio] The Polymer Vials initiative is a significant component of our Innovation week project. These vials have been developed to reduce the risk of breakage compared to traditional glass vials resulting in fewer instances of product loss and waste. This can lead to substantial cost savings for pharmaceutical companies by reducing the need for replacement vials and minimizing downtime during production. However to ensure compliance with regulations additional testing and quality control measures may be necessary. The decision between glass and polymer vials depends on several factors including product requirements budget constraints and overall cost-effectiveness for pharmaceutical companies..

[Audio] Manufacturing polymer vials in India is not without challenges. The production process of polymer vials can face several difficulties including: * Consistent quality is essential to meet regulatory requirements and ensure the safety and efficacy of pharmaceutical products. * Sourcing high-quality polymer resins and additives for vial production can be challenging particularly when sourcing materials that meet regulatory standards for pharmaceutical packaging. * Achieving and maintaining sterility in polymer vial manufacturing is critical for packaging injectable pharmaceuticals. * Designing polymer vials that meet the specific requirements of pharmaceutical products can be complex and require balancing various factors such as compatibility ease of use and tamper resistance. * Compliance with regulatory requirements for pharmaceutical packaging can be complex and time-consuming. * Manufacturing polymer vials at competitive prices while maintaining quality and regulatory compliance can be challenging due to rising raw material costs energy expenses and labor costs. * Investing in advanced manufacturing technologies and equipment for polymer vial production requires significant capital investment and technical expertise. * Environmental concerns can arise from polymer vial manufacturing processes which can generate waste and consume resources. To address these challenges manufacturers must adopt a multi-faceted approach that includes investment in technology and infrastructure robust quality management systems collaboration with suppliers and regulatory authorities and ongoing efforts to optimize processes and reduce costs..

[Audio] Our initiative on Polymer Vials is a crucial contribution to the Innovation Week project. As regulations for pharmaceutical vials become increasingly stringent ensuring the quality of approved drugs remains paramount. Pharmaceutical regulations extend to packaging and can directly impact critical product attributes. Pharma manufacturers control their primary packaging to all relevant international standards and apply a rigorous selection process to all suppliers verifying qualifications and performance. Pharma products are produced in facilities operating under a quality management system certified compliant to ISO 15378 standards where G-M-P requirements for pharmaceutical primary packaging are consistently applied. We believe that our Polymer Vials initiative will further contribute to this ongoing effort to ensure the safety and efficacy of pharmaceutical products..

[Audio] We understand the importance of packaging in the pharmaceutical industry. Manufacturers must ensure the safety durability and compatibility of the packaging material with the product it contains. Comprehensive documentation sterility and cleanliness requirements labeling requirements and compatibility testing are all essential components of packaging compliance. The packaging of injectable polymer vial products must be designed to facilitate safe and convenient handling storage and administration while preventing contamination and tampering. We must stay informed of any regulatory requirements and standards to ensure compliance with the law. Seeking guidance from regulatory experts or legal professionals can help navigate the regulatory landscape..

[Audio] Our company has developed new polymer vials for the phytosanitary industry that comply with the ISO 15378 Standard International Standard for Phytosanitary Measures 15 (ISPM 15) on wood materials. These vials meet the standards set by the European Pharmacopeia United States Pharmacopeia Japanese Pharmacopeia and Chinese Pharmacopeia. Additionally our polymer vials are fully compliant with the EU Regulations and Directive providing peace of mind to our customers that they are using a product that meets all necessary standards. Our innovative approach to phytosanitary measures ensures that our polymer vials are both sustainable and effective in preventing the spread of plant diseases. We offer our customers a solution that meets the highest standards and contributes to the preservation of our planet's natural resources..

[Audio] Polymer vials are a type of plastic container used in many different industries. They are made from a combination of polymers which are long chains of molecules that are linked together. These molecules can be made from various materials such as polyethylene polypropylene and polytetrafluoroethylene. Polymer vials are popular because they are strong durable and can withstand a wide range of temperatures and chemicals. They are also lightweight and easy to handle making them ideal for use in many different applications. One of the key features of polymer vials is that they can be sterilized using a variety of methods including autoclaving gamma irradiation and ethylene oxide gas. This makes them ideal for use in the pharmaceutical industry where sterility is critical for ensuring the safety and efficacy of drugs. In addition to being sterilized polymer vials can also be tested for a variety of microbiological and biological properties. For example they can be tested for microbial enumeration bacterial endotoxins and sterility. These tests are important for ensuring that the vials are safe and effective for use in various applications. Polymer vials can be registered with the relevant regulatory authorities in various countries including the U-S F-D-A Health Canada and the N-M-P-A (formerly the Chinese FDA). This is important for ensuring that the vials meet the appropriate safety and efficacy standards and can be used in various applications..

[Audio] Advancements in polymer science and manufacturing technology have led to the development of innovative polymer vial designs and materials with enhanced performance characteristics. These advancements enable manufacturers to meet evolving regulatory requirements improve product protection and enhance patient experience. Stringent regulatory requirements for pharmaceutical packaging drive the demand for high-quality polymer vials in the Indian market and manufacturers are increasingly investing in compliant packaging solutions to ensure regulatory compliance and product safety. Moreover pharmaceutical companies seek cost-effective packaging solutions that offer value for money and polymer vials provide advantages such as lightweight construction reduced transportation costs and lower risk of breakage compared to glass vials. The polymer vial market in India is poised for continued growth as pharmaceutical companies seek packaging solutions that offer safety performance regulatory compliance and cost-effectiveness. Collaboration between packaging manufacturers pharmaceutical companies and regulatory authorities will play a crucial role in driving innovation and meeting the evolving needs of the market..

[Audio] The pharmaceutical industry in India is constantly expanding due to increasing demand for single-use packaging solutions and advancements in polymer technology. PP vials are a popular packaging solution in the Indian pharmaceutical industry due to their advantages such as flexibility lightweight construction and reduced risk of breakage. They are suitable for single-dose applications. PP vials must meet stringent regulatory requirements set by authorities such as the Central Drugs Standard Control Organization (C-D-S-C-O) and must comply with pharmacopoeia standards and regulatory guidelines to ensure product safety and efficacy. Pharmaceutical packaging manufacturers in India are investing in advanced manufacturing technologies and equipment to meet the growing demand for PP vials. This includes investments in injection molding machines quality control systems and automation to enhance production efficiency and product quality. The PP vial market in India is competitive with both domestic and international players competing for market share. Domestic manufacturers often focus on offering cost-effective solutions tailored to the needs of the local market while international manufacturers may emphasize innovation and technology..

[Audio] The pharmaceutical packaging market is growing rapidly due to global demand for pharmaceuticals. Biologics and biosimilars require specialized packaging solutions to ensure product stability and integrity. PP vials are preferred for packaging biologics due to compatibility with a wide range of drug formulations and reduced risk of leachable and extractables. Innovative PP vial designs have been developed to improve barrier properties compatibility with sterilization methods and customization options. Regulatory harmonization initiatives aim to simplify regulatory requirements for pharmaceutical packaging across different regions promoting market access for PP vial manufacturers. Sustainability is a growing concern in the global packaging industry including pharmaceutical packaging and PP vials offer environmental benefits such as recyclability lightweight construction and reduced carbon footprint compared to traditional packaging materials. Emerging economies particularly in Asia-Pacific and Latin America provide lucrative growth opportunities for PP vial manufacturers due to increasing demand for pharmaceuticals and infrastructure development in these regions. The PP vial market in both India and globally is expected to continue its growth trajectory driven by factors such as the expansion of the pharmaceutical industry technological advancements regulatory compliance and sustainability considerations. Manufacturers that can offer high-quality cost-effective PP vial solutions tailored to the needs of pharmaceutical companies are well-positioned to capitalize on these growth opportunities..

[Audio] Based on market insights and feedback from lead customers we have identified targeted polymer grades and have plans to conduct trials. Our pilot mold development plan will be discussed with Daksh for further assessment. We would like to present our findings to directors next month and seek their feedback..