Specialty Coating Systems, Inc.
Terumo Europe NV
- Service Details
SCS’ leadership in providing world-class Parylene coating services for the medical device industry is more than just a point of difference. The company’s resources, experience and expertise enable design engineers to design with confidence, knowing that SCS’ thin-film, pinhole-free Parylene
There are several pharmaceutical companies manufacturing prefilled syringes as preferred delivery device for at least 50 injectables drugs and vaccines. Prefilled syringes are now used across a wide array of therapeutics sectors outside of the traditional domains of anticoagulants and vaccines. The use of prefilled syringes is expected to accelerate over the coming decades. For the pharmaceutical company, the advantages of prefilled syringes are minimizing drug waste; increasing product life span and enhancing level of market share are some of driving market demand. For healthcare workers, prefilled syringes are recognized as an efficient, reliable and convenient method for drug administration. Furthermore, the ease at which patient can self-administer many types of injectables drugs make prefilled syringes of healthcare treatment out of hospital and into home. As global contract manufacturing leader in prefilled syringe fill-finish, such service providers offer clinical through high-volume commercial sterile manufacturing. Redundant like-in-kind filling lines can help increase production potential, mitigate supply risk and ensure on-time delivery. By providing high-speed, high-volume syringe filling, which mirrors packaging capacity with automated inspection, labeling, and final packaging, contract manufacturers have the resources and experience to get their clients to market. Contract Manufacturing companies dealing in PFS offer a continuous workflow for a range of prefilled syringes, packaging and supply options, including Disposable syringe manufacturing, Safety syringes, Sterile injectables, Prefilled syringe packaging. With the use of sophisticated fill finish techniques and equipment – including Restricted Access Barrier System (RABS) technology –Contract Manufacturers bring total efficiency to the full syringe manufacturing workflow. Their competitive advantage comes through a combination of people, processes and tools, including: An aseptic filling suite utilizing RABS technology; Filler utilizing peristaltic pump technology; Fill volumes from 0.4 mL – 8 mL (in BD Hypak or equivalent type syringe utilizing the SCF Format); 100% visual inspection; Compatible with closures packaged in rapid transfer port system; Cold chain warehousing; On-site microbial laboratory, chemistry and testing Contract Packaging Organizations for Pre-Filled Syringes offer broad packaging capabilities like: Injector Assembly: Packaging engineering experts on-site; Fully automated auto injector assembly; 100% visual and automated inspection during syringe manufacturing; Labeling and cartoning of auto-injectors Syringe Packaging: Fully automatic assembly for plunger and finger grips; Labeling of individual syringes; Blister packaging and cartoning for individual syringes; 100% visual and automated inspection. Contract manufacturing, filling and packaging services offered by service providers for Pre-Filled Syringes are available with following capabilities: Filling of products in prefilled syringes according to cGMP; State-of-the-art aseptic commercial multi-product facility; Syringes are filled under state-of-the-art conditions within a restricted access barrier system (RABS); Glass and plastic syringes with fill volumes of 0.5 - 10 mL delivered by qualified suppliers of primary packaging; Batch sizes ranging from pilot scale to commercial scale; Automated visual inspection; Ready-to-use stoppers. Requirements of the package for Pre Filled Syringes The pre-filled syringe is an example of a high-value product that must be safeguarded throughout a long shelflife and yet be readily and accurately used whenever required. The proper selection of the package and the attention to its design will promote the benefits of the product in addition to fulfilling these fundamental functions. The syringe is not viable without a primary package. The package must enable rapid access to each of the pre-filled syringes it contains. The package must remain intact until the last of the syringes has been removed if that last syringe is to be safeguarded. The printing of the package will clearly present essential product information. Further features may confirm that the syringe is untouched until required for use. A reclosable package can be retained for subsequent use without difficulty. If the package contains a course of treatment for a single patient, features to assist dosage compliance are appropriate. If the contents are to be used over an extended period, opening features that release only one syringe at a time can assist the user.
ABOUT THE PAGE