In pharmaceutical powder packaging, antistatic PE packaging is widely used as it maximizes product recovery and reduces the risk of potential powder explosion due to static charge build-up.Traditional antistatic LDPE however has certain disadvantages, including short shelf life and material-borne contamination, due to the migrating antistatic agent used in the film manufacturing process..
Newform Permanent Antistatic LDPE Packaging overcomes these limitations with its Permanent Static Dissipative (PSD) LDPE film that supports a full range of medical compliances.颇尔’s cGMP compliant quality approach, ultra-clean extrusion technology, and state-of-the-art ISO Class 5 cleanrooms delivers an antistatic packaging product that is safe, pure and effective, with long shelf life.
All 颇尔® PSD film-based products, including bags, drum liners, tubes, sheets or customized shapes are gamma-sterilizable, or can be delivered pre-sterilized on request.
特点
- In-house extrusion of LDPE film (150 micron/6 mil)
- Blown-film extrusion of LDPE film, conversion and packaging in certified ISO Class 5 cleanrooms cGMP focused manufacturing
- Notification of Change policy prior to change on resin composition, manufacturing process or regulatory status
- Certificate of Conformance with each delivery
-
In-process testing on each batch:
- Dimensions (width, length, thickness)
- Cleanliness (particle count)
- Surface resistivity
- Seal strength
- Integrity (dye-penetration test with methylene blue)
优势
- Longer shelf life compared to that of traditional antistatic LDPE packaging
- Stable, superb surface resistivity
- Antistatic properties independent of humidity
- No sticking of powder to the film (99.9% product recovery)
- Low visible and subvisible contaminants level
- Low bioburden and endotoxin level
- Certified cleanliness level
- Improved process efficiency
- Gamma sterilizable up to 50 kGy
- Pre-sterilized bags available upon request (gamma irradiated at 25 kGy, certified)
优质
- Film is Animal-Derived-Component-Free (ADCF)
Compliant to:
- FDA Title 21 CFR 177.1330 ‘Olefin Polymers’
- EU Directive 10/2011 (food contact approval)
- USP<87> Biological Reactivity test in vitro
- USP <88> Biological Reactivity test in vivo, class VI
- USP <661> Physicochemical test – plastics
Packaging and/or gamma sterilization of:
- Active Pharmaceutical Ingredients (API)
- Bulk Pharmaceutical Chemicals (BPC)
- Pharmaceutical Powders
- Excipients
- Tablets
Part Number | Opening By Length | Pkg |
PSDE10-0000-0002 | 200 mm x 300 mm | 1000/box |
PSDE10-0000-0003 | 300 mm x 450 mm | 1000/box |
PSDE10-0000-0004 | 450 mm x 600 mm | 500/box |
PSDE10-0000-0005 | 600 mm x 800 mm | 1500/box |
Customized sizes available upon request
All bags labeled and double packed per 100 pieces and delivered with a Certificate of Conformity
Standard thickness:100 μm.Other thicknesses available upon request
Can be delivered gamma-irradiated upon request and delivered with a Certificate of Sterilization
Width equals opening of bag
Certificate of Analysis available upon request
Additional Services
Part Number | 描述 |
LABIRSCOA | Infra-Red Test Report |
LABMECHCOA | CoA for cleanliness, seal strength, dimensions, surface resistivity (if applicable) |
LABMICROLAL | CoA for bacterial endotoxins; 1 x LAL test |
LABMICROTVC | CoA for bioburden TVC |