Frequently Asked Questions

We offer RTU glass vials and RTU glass cartridges for aseptic filling applications. These ready-to-use formats are designed for pharmaceutical customers who need clean, sterilized, and filling-ready primary packaging.

Our RTU vials are supplied ready to use. Customers do not need to perform washing, depyrogenation, sterilization, or drying before filling, allowing the vials to go directly into the aseptic filling process according to their operating procedures.

RTU cartridges are designed for cartridge-based drug delivery systems, including injection pens and pump systems. They support high dosing accuracy, stable piston movement, and efficient aseptic filling.

Our RTU products follow a controlled cleaning process that includes one cycle of clean compressed air, two cycles of purified water, and two cycles of Water for Injection. The process is supported by 0.25 μm filtered clean air to help maintain pharmaceutical-grade cleanliness.

For applicable RTU products, endotoxin can be controlled below 0.25 according to agreed specifications and testing requirements.

Our RTU products can be supplied in Tray or Nest & Tub formats. Nest & Tub packaging provides non-contact protection to reduce glass-to-glass contact, scratches, particles, and breakage risk, while Tray packaging can support different handling and filling requirements.

Yes. Our RTU vials and cartridges are designed to support mainstream automated filling, stoppering, sealing, and inspection processes.

RTU vials are suitable for vaccines, mRNA vaccines, biologics, blood products, monoclonal antibodies, oncology drugs, lyophilized drugs, and high-value injectable formulations.

RTU cartridges are suitable for insulin, GLP-1 therapies, HGH, biologics, dental anesthetics, blood products, and other cartridge-based injectable therapies.

Yes. RTU products can help reduce the need for customer-side WFI systems, depyrogenation tunnels, sterilization equipment, cleanroom space, and preparation labor.

We offer standard glass vials, standard glass cartridges, molded bottles, ampoules, PFS-related solutions, pen injectors, pharmaceutical glass tubing, rubber stoppers, and caps.

Our key recommended products are RTU vials, RTU cartridges, standard cartridges, standard vials, and PFS solutions.

We focus on pharmaceutical-grade borosilicate glass,like Type I neutral borosilicate glass, which supports chemical resistance and drug stability.

Type I borosilicate glass is widely used for pharmaceutical primary packaging because it provides high hydrolytic resistance, strong chemical durability, low alkali release, and reduced risk of trace metal release, including elements such as lead, cadmium, arsenic, chromium, nickel, and aluminum. It also offers good thermal stability and mechanical strength, helping protect sensitive formulations, support pH stability, reduce container-drug interaction risk, and improve reliability during filling, sterilization, storage, and transportation.

Yes. Selected vials, cartridges, RTU formats, and PFS solutions can support biologics, subject to compatibility evaluation.

Yes. Our vial and RTU vial solutions can support conventional vaccines, mRNA vaccines, and other vaccine packaging projects.

Yes. Our cartridge products are designed for pen injectors and other drug delivery systems where inner diameter consistency and piston performance are critical.

Yes. Dual-chamber cartridge options can be discussed for powder-and-solvent combinations where separated storage and simplified reconstitution are needed.

Yes. We support PFS-related packaging needs, including needle syringes, taper tip syringes, and luer lock syringes. Available size options include 1ml long, 1ml, 2.25ml, 3ml, 5ml, and 10ml, supporting applications for injectable drugs, biologics, and advanced drug delivery systems.

Yes. We supply molded glass bottles for injection, infusion, medicine, healthcare, and selected specialty packaging applications.

Yes. We supply pharmaceutical glass ampoules for injectable drugs, sterile liquids, and selected laboratory applications.

Yes. We serve laboratories requiring reliable pharmaceutical containers for reagents, samples, testing, storage, and controlled applications.

Yes. We can support large pharmacies and compounding-related customers with suitable sterile and non-sterile pharmaceutical packaging options, backed by large-scale annual capacity: RTU cartridges 10 million pcs/year, RTU vials 70 million pcs/year, PFS 120 million pcs/year, Type I molded bottles 800 million pcs/year, vials 50 million pcs/year, and cartridges 100 million pcs/year.

Yes. We can review customized requirements for capacity, dimensions, finish, bottom design, coating, packaging format, and technical specifications.

Yes. V-bottom vial options can be discussed for applications where reducing residual volume is important, such as selected lyophilized drugs.

Yes. Coated vial options can be discussed for special formulations requiring enhanced performance or specific interaction control.

Yes. We can support laboratory evaluation, clinical development, scale-up, validation, and commercial supply based on project requirements.

Linuo’s Brazilian factory helps customers strengthen supply chain security, diversify supply sources, and reduce dependence on a single manufacturing region. It also supports faster delivery, localized service, and customized production for customers in South America, the Americas, and global markets.

Yes. We serve customers in regulated markets, including Europe, North America, Latin America, and other global regions. For the U.S. market, we also have a local company and warehouse at 38 Thomas, Irvine, CA, supporting faster response, local service, and more efficient supply coordination.

Linuo provides a one-stop pharmaceutical packaging solution, combining a complete pharmaceutical glass packaging portfolio, Type I borosilicate glass expertise, RTU and standard product options, PFS capabilities, CNAS-accredited testing support, overseas manufacturing bases in Brazil and Egypt, China-based production strength, and long-term stable supply support.

RTU quality is controlled through defined cleaning, drying or purging, filtered clean air, inspection, sterile barrier packaging, sterilization, testing, and batch release procedures.

For applicable RTU products, endotoxin can be controlled below 0.25 according to agreed specifications and customer testing requirements.

Our RTU products are cleaned with 85°C Water for Injection to support pharmaceutical cleanliness and reduce contamination risk before filling.

RTU products are treated with five cycles of clean compressed air after cleaning, helping remove residual moisture and support cleanliness control.

The RTU process is supported by 0.25 μm filtered clean air to help reduce airborne contamination risk.

Particle risk is reduced through controlled cleaning, filtered clean air, clean compressed air treatment, non-contact Nest & Tub packaging, clean-peel technology, and inspection.

Yes. Our RTU packaging is designed to support transfer into high-grade aseptic filling environments, including Grade A applications, according to customer procedures.

RTU products can be supplied with terminal ETO sterilization according to product configuration, customer requirements, and agreed specifications.

Yes. For applicable RTU products, we can provide sterilization-related documents, endotoxin-related documents, inspection records, specifications, and batch release documents.

RTU products help reduce customer-side preparation steps, manual handling, and contamination control burden, supporting more consistent aseptic filling preparation.

Our quality approach includes controlled production, inspection procedures, batch traceability, specification management, quality documentation, and customer-specific quality alignment.

Yes. We can provide technical and quality documents based on product type, customer specifications, target market, and project requirements.

Documents may include product specifications, certificates of analysis, compliance statements, material information, batch records, inspection reports, and testing documents.

Yes. We can support supplier qualification with company information, manufacturing capability details, product documents, quality records, and audit cooperation.

Yes. For qualified projects, customer audits can be arranged based on project stage, business needs, quality requirements, and confidentiality agreements.

Our products are designed to support customers serving regulated markets such as Europe, the United States, Latin America, and other global regions.

Project materials indicate support such as ISO 15378, FDA DMF registration, Health Canada MF registration, EU CEP, Russian certification, and compliance alignment with USP, EP, JP, and ChP where applicable.

Yes. Linuo has a CNAS-accredited laboratory to support pharmaceutical packaging testing and quality evaluation.

Testing capabilities include material analysis, chemical analysis, dimensional measurement, appearance inspection, physical and mechanical testing, and related pharmaceutical packaging evaluations.

Batch consistency is managed through controlled processes, in-process checks, final inspection, batch records, MES traceability, and release procedures.

Yes. MES-based traceability can support quality management, audits, investigations, and regulated supply requirements.

We control dimensional tolerance through precision forming equipment, defined product specifications, in-process quality monitoring, and final inspection standards. Critical dimensions are checked by 360° automated inspection and AI intelligent inspection systems to support filling line compatibility, sealing performance, stoppering, capping, and end-use performance.

We apply inspection standards and automated inspection where applicable to control cracks, chips, scratches, stains, deformation, contamination marks, and other visible defects.

Yes. Project materials show 100% CCD/AI inspection support for RTU lines and AI inspection capabilities across smart manufacturing systems.

Breakage risk is reduced through material control, process stability, dimensional accuracy, non-contact packaging options, protective packaging, and proper logistics configuration.

We can provide relevant material and product information to support customer extractables and leachables assessment. Final evaluation should be based on the customer’s formulation.

We support customers with suitable glass selection, product information, technical discussion, and compatibility evaluation based on formulation risk.

Yes. We can review customer-specific requirements and align inspection, documentation, packaging, release standards, and quality agreements where feasible.

The Brazil facility has passed ANVISA certification and provides an additional regional manufacturing source. This helps customers reduce dependence on a single supply region, strengthen long-term supply resilience, and better serve regulated markets in South America and beyond.

Linuo combines pharmaceutical glass expertise, RTU and standard product options, Type I borosilicate capability, CNAS testing, AI inspection, MES traceability, regulatory documentation support, and China-Brazil manufacturing flexibility.