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On March 1st, 2023, the General Chapters-Packaging and Distribution Expert Committee has published the revision proposal to General Chapter <660> Containers – Glass in the Pharmacopoeia Forum (PF) 49 (2) [March-April 2023], with a comment deadline of May 31, 2023. After all the comments have been addressed by the Expert …

The 11608:2022 series addresses requirements for needle-based injection systems such as OBDS. Per the standard, to qualify as an injection system, "the time or speed employed to deliver a discrete volume would be based upon tolerability or convenience rather than clinical relevance (e.g., medication efficacy) as would be the …

Injectable drug products have rigorous requirements for the presence of both visible and subvisible particulates. Current guidance on analytical methods and particulate matter limits in injectable drug products are published in national and regional pharmacopeias. Requirements include being essentially free of visible particulates.

Use of a cyclic olefin polymer vial, like the Daikyo Crystal Zenith® vial, can help mitigate the risks associated with cryogenic storage. Daikyo Crystal Zenith vials are made from a break-resistant cyclic olefin polymer that has excellent thermal characteristics and can withstand cryogenic temperatures as well as sterilization by autoclave.

To enable this, West offers Flip-Off ® CCS seals (clean, certified, sterilized) that are ready-to-use for aseptic crimping inside Grade A environments. Flip-Off CCS seals are an ideal choice for small quantity filling of high-value drugs, like cell therapies. The buttons are manufactured from a gamma-stable polypropylene resin and are washed ...

E-beam sterilization has many advantages; it is convenient, gentle and effective. E-beam sterilization can be performed continuously on product in its final package (e.g., product supplied in nests used in flexible fillers). Compared to steam sterilization, it operates at a much lower temperature, and is suitable for products having hard-to ...

Indeed, the particle limits in USP<789> Particulate Matter in Ophthalmic Solutions are stringent - effectively allowing less than one single particle greater than or equal to 25 microns in a syringe filled with a dose of 0.1 mL. Interestingly, although USP<789> is directly applicable for intravitreal injections, the particle limits contained ...

Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and …

Needle siliconization – needles with low or inconsistent siliconization cause increased coring and fragmentation. Needle reuse – reuse will dull a needle, remove silicone and increase the chance of coring and fragmentation. Force of puncture – higher needle insertion forces increase the tendency for coring. Angle of puncture – needle ...

However, vials with inserted stoppers are moved on the tracks of the Fill & Finish line and there may be occurrences of stopper pop up. The extent of these raised stoppers may be described as ranging from partially-lifted stopper flanges, to stoppers being lifted from vials, to the worst-case scenario of stoppers removed from vials completely.

Available in nested 13mm and 20 mm vial sizes, the DAIKYO PLASCAP RUV vial closure includes the following features: Integrated Flurotec ® laminated stopper and plastic cap system are manufactured in a Daikyo ISO 7 clean room to control particulate cleanliness and bioburden. One-step, press-fit vial closure process integrates …

Our extensive global network of 25 manufacturing sites across the globe is supporting customers with the production of elastomer stoppers, plungers and aluminum seals. Overall, West produces about 40 billion components and devices a year. Our products continue to create value for our customers. The choice of which high-quality …

The facility will also handle the warehousing and release of other ready-to-use Crystal Zenith systems such as vials and bulk drug containers. "We found a high level of interest in the Crystal Zenith insert needle syringe system during its formal launch at a customer open house in Scottsdale last October," said Donald E. Morel, Jr., Ph.D ...

Component Compatibility. When converting a drug product from its initial container closure system to a prefillable syringe system or device, component elastomer formulations and sterilization mode equivalency can help ease the transition, minimize regulatory filing times and mitigate risk for pharmaceutical manufacturers. West's global ...

Manual Filling Method for Crystal Zenith Insert Needle Containers for Compatibility Testing Manual filling method for Stability Testing with CZ syringes For functional testing, like CCI or Needle Shield Pull-off, West recommends a represented fill-finish method.

Blunted bevel heel and sharp point. Use only once. Consistent lubrication on the needle surface. Technique: Puncture within the target circle on the stopper. Insert at proper angle. Insert needle slowly. Do not rotate during insertion. Note, multiple …

West is pleased to announce that we've recently expanded our Online Store offerings to include a 20mm NovaPure ® Ready Pack™ lyophilization stopper, adaptiQ ® vials from SCHOTT and Ready Pack™ Flip-Off ® CCS (Clean, Certified, Sterilized) seals. West's Online Store is a one-stop solution for access to small quantities of some of …

Aluminum seals with plastic buttons, such as West Flip-Off ® Seals (FOS) and. West Flip-Off Tear Off Seals (FOTOS) allow for one-handed opening. Available color-coding on buttons enhances drug identification and market differentiation. 1 They provide tamper evidence (i.e., once the button is removed, it cannot be re-attached properly).

Daikyo Crystal Zenith® Vials; Corning® Viridian™ Vials; Corning Valor® Glass Vials; SCHOTT adaptiQ® Vials; SG EZ-fill® Vials; Daikyo Crystal Zenith® Insert Needle Syringe Systems; Daikyo Crystal Zenith® Ophthalmic Luer Lock Syringe; …

The benefits of pre-filled syringes based on Daikyo Crystal Zenith ® cyclic olefin polymer (COP) Technical article consider the benefits of prefilled syringes based on Daikyo Crystal Zenith® cyclic olefin polymer by reducing the risk of interaction with drug product.

Cell therapies are stored at cryogenic temperature (approximately -180 o C, vapor of liquid nitrogen). By providing container closure integrity (CCI) under this condition, primary package systems based on Daikyo Crystal Zenith ® cyclic olefin polymer (COP) vials have a clear advantage over systems based on glass vials.. This was the focus of …

In order to mitigate the risks these events pose to patient safety, we can add a layer of a solid fluoropolymer film, known as FluroTec ® film. This film is directly laminated onto the elastomer components during the molding process. The effectiveness of the barrier depends on its quality and thickness. FluroTec ® film provides consistent ...

A Team Member Perspective: My SmartDose. ®. story. I've worked at West for 28 years. I lead our Venture Group, Global Labs, and Data Science Team; I've spent most of my career in R&D. There's an expectation from our customers that West will lead the way in developing new products. Ones that are going to be better for patients, easier …

For further information on the Daikyo Crystal Zenith® 2.25mL Insert Needle Barrel Assembly and related components, please contact your account representative or visit the site below to browse product attributes and additional resources.

The endotoxin test method was developed with strong focus on endotoxin recovery from all representative elastomer components. A limit of quantification as low as 1 EU/pc could be successfully achieved during the test method validation. West strives to provide the highest level of support to customers by delivering industry-leading scientific ...

The soft needle shield can be manufactured in multiple West elastomeric formulations, such as 7025/65 grey and 7028/55 grey. The 7025/65 grey formulation is a blend of a synthetic polyisoprene and a bromobutyl and is a well-known formulation used for multiple approved drugs in the pharmaceutical market. The 7028/55 grey formulation is …

Page 22 Insert locking pin Zenith 1) Locked 2) Unlocked Insert the locking pin (7) through the holes under the seat base, keeping it in unlocked position to allow final adjustment later on. zoom 1) Bloqueado staan om later de eindafstelling toe te Insérez la goupille de verrouillage Vlozte blokovaci kolik (7) cez otvory 2) Desbloqueado laten ...

цайны өрөм - аяга, саванд хийсэн цай хөрөхөд дээгүүр нь тогтох нимгэн хөрс. эргүүл өрөм - аливаа механизмийг эргүүлэн цоолох төхөөрөмж. ээрүүл өрөм - юманд нүх гаргах багаж. цахил­гаан өрөм ...

To minimize this risk, an alternative is needed. This is addressed in a new report by West scientists: Alternative for SARS-CoV-2 Vaccine Primary Package Systems: Daikyo Crystal Zenith ® Cyclic Olefin Polymer Vials. These vials have excellent performance features: Low levels of extractables. Low levels of interaction with drug …

In addition to sterilizable bags, West offers closures in aseptic transfer bags – referred to as "port bags" or "ported bags.". Port bags contain a "beta" port that is attached to the actual bag (Figure 1). …

Consistent Crimp, Consistent CCI. Container closure integrity (CCI) is a critical factor every drug manufacturer and compounder is required to achieve. To achieve CCI, one must consider factors such as vial material, blowback, and stopper design. One vital factor – too often an afterthought – is the aluminum seal. Example of a good crimp ...

Blunted bevel heel and sharp point. Use only once. Consistent lubrication on the needle surface. Technique: Puncture within the target circle on the stopper. Insert at proper angle. Insert needle slowly. Do not rotate during insertion. Note, multiple punctures increase the chance of coring and fragmentation.