The need for a rapid sterility testing solution is greater than ever before. More importantly, the need for a complete RMM validation solution to reduce the time between purchase and routine use is more critical than ever. Learn how Celsis® for sterility, a modular solution, enables you to validate a system in less time with our new validation and implementation support packages. Get Started

Septa for use with general chromatography vials, liquid injection 2-056 PTFE/Natural Red Rubber PTFE Natural Red Rubber are moderately priced seals for GC and HPLC with good chemical properties. They are ideal for multiple injections due to high resealability, but not as easy to penetrate as PTFE/RR.

May 31, 2019 · 81 applicant is advised to offer justification for the testing program chosen. 82 2. SCOPE 83 Packaging/delivery systems that have elastomeric components and are 84 within this chapter’s scope include vials and bottles with elastomeric 85 stoppers; syringes with elastomeric plungers that have needle shields or tip

Test Product ≥ 10 µm ≥ 25 µm Light Obscuration Small volume Parenterals 6000/ container 600 / container Large volume Parenterals 25/ml 3/ml Microscope Small volume Parenterals 3000/ container 300 / container Large volume Parenterals 12/ml 2/ml • Given that “product” includes three components (drug product, vial, stopper)

Jan 13, 2016 · The coring and fragmentation of elastomer components used in containment of parenteral drug products continues to be a challenge. Many factors influence these phenomena, so it is critical that a pharmaceutical manufacturer understands how a vial system will be used, for example: what is the recommended needle gauge; is it single- or multi-dose; could spikes, vial adapters or closed system

Jun 1, 2019 · 12. RELEASE INSPECTIONS AND TESTING 12.1 Visual Inspection 12.2 Sterility Testing 12.3 Bacterial Endotoxins Testing 13. LABELING 14. ESTABLISHING BEYOND-USE DATES 14.1 Terminology 14.2 Parameters to Consider in Establishing a BUD 14.3 Establishing a BUD for a CSP 14.4 Multiple-Dose CSPs 15. USE OF CONVENTIONALLY MANUFACTURED PRODUCTS AS COMPONENTS

With adaptiQ®, SCHOTT Pharma offers gold-standard borosilicate vials in a pre-washed and pre-sterilized ready-to-use (RTU) configuration in highly standardized secondary packaging. The vials maximize the flexibility of the filling line while increasing patient safety. Find out more.

Feb 1, 2016 · The evaluation of container quality attributes was performed for three model glass vials using a mechanical and chemical durability testing platform: freeze-thaw, lyophilization, compression, scratch tests; visual inspection, pH, particle size analyses, extractable, leachable and imaging studies that were conducted under normal (4 and 25 °C

Setting a maximum volume in multiple-dose vials will 88 minimize vial septum punctures, which will reduce the risk of compromising vial integrity and 89 . the potential for vial contamination. 90

complete discussion of fitness-for-intended-use testing, as compared to closure functionality assessment in early package development, is presented in Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems 1382 that is being proposed in this issue of PF. Also refer to 1382 for guidance on test

Mar 2, 2021 · Note that although the European Pharmacopeia (EP 3.2.9) specifies a 21 gauge needle for testing, hospitals often use larger needles, such as 18 gauge. piercing : angle, speed, direction, number of piercings, and locations of piercing (see West Technical Report 2020/223 Impact of Piercing Techniques on Stopper Coring and Fragmentation )

Apr 18, 2019 · Syringe plunger septum!!! We recommended that the client audit their manufacturing process with respect to light grey rubber sources (e.g. gaskets, o-rings, septa) They could also approach their suppliers as the particle may have an upstream source The septum is a black rubber, so it is ruled out as a potential source of the particle

224 difficult to access. One approach for disinfecting the vial septum in this type 225 of vial shield is to use a right-angle forceps to hold a sterile 70% IPA wipe 226 and direct it down onto the vial septum. It is also acknowledged that such 227 vial shields will disrupt first air contacting the vial septum during certain 228 handling

This method of leak test of the colored vial in pharmaceutical manufacturing usually used for pharmaceutical blister packaging. This simple visual test is the oldest of the three testing methods. It uses methylene blue dye or another colored chemical liquid to determine whether there is a leak or not.