Ophthalmic

Many CPO’s offer to pharmaceutical industry plastic packaging and widely varied spectrum of packaging solutions within solid, liquid and ophthalmic applications.. Standard range includes a wide choice of different types of containers and closures, PET bottles, eye droppers, nasal sprays, nebulisers as well as numerous customized developments. Unit dose blow/fill/seal vials for one-time ophthalmic use have become an accepted international standard. The ASEP-TECH Advantage is reflected in the development of formulations that no longer contain preservatives, minimizing the risk of allergic reactions for patients. Unit dose blow/fill/seal vials for one-time ophthalmic use have become an accepted international standard. The incorporation of a tip and cap insert into the blow/fill/seal package to produce a calibrated drop. Pharma Packaging solutions offers a full range of primary plastic packaging for ophthalmic products. Their impressive product range includes standard containers, droppers and closures in numerous designs and sizes as well as products customised to specific customer designs. Today, they offer a large range of proprietary eyedroppers with packaging that fits your requirements in terms of appearance, barrier properties, drug compatibility, filling volumes and drop size. Bottles, droppers and closures are manufactured in cleanrooms compliant to ISO Class 7. They also have extensive experience in managing the sterilization process qualification according to ISO 11137. Products & Features Dispensing systems including dropper bottles, nozzles and closures Sizes ranging from 4 ml to 550 ml Tamper-evident systems Containers made of HDPE Droppers and closures in HDPE, LDPE and PP Printing on containers (dry-offset and silk screen) Compliant Quality In general, the products have full conformity with the European Pharmacopoeia, the United States Pharmacopeia with Drug Master Files. Certified in accordance with ISO standards 15378, 9001, and 14001. In-line camera vision inspection systems Integrated metal detection systems Detailed product documentation Good Manufacturing Practice (GMP) protocols in place Cleanrooms compliant to ISO Class 7 and ISO Class 8 Batch documentation is retained for at least 5 years Full traceability throughout the manufacturing process Automated dimensional qualification and checking Managing sterilization process qualification according to ISO 11137 The FDA-guidance, “Container Closure Systems for Packaging Human Drugs and Biologics” of 1999 makes a classification of pharmaceutical container closure systems, based upon the Likelihood of Interaction between the dosage form and the packaging, but also based upon the degree of concern associated with the route of administration. If the requirements for a container closure system would not be clear or conclusive, the FDA encourages discussing the documentation in container/closure requirements with the appropriate CDER chemistry review staff or CBER review staff. In Europe, the EMEA- Guideline on Plastic Immediate Packaging Materials of 2005, both solid and non-solid products for ophthalmic administration require the same level of immediate packaging requirements as parenterals and inhalables. A first step herein is to demonstrate compliance for the plastic material to the European Pharmacopoeia. However, for non-compendial plastic materials used of ophthalmic administration, extraction studies are required even if they are approved for the use in food packaging. The decision tree in the EMEA-Guideline indicates that for non-solid dosage forms, Interaction studies (which include migration studies to monitor the leaching of substances from the plastic material into the formulation) are considered as a requirement. For solid ophthalmic dosage forms, interaction studies should be performed “when necessary”. Although label migration is not a specific requirement for ophthalmic pharmaceuticals, it is often a concern for these types of products. In numerous cases, it has been shown that label components (such as adhesive compounds, photo-initiators, curing agents, ink residues) were able to migrate through the polymer container into an ophthalmic drug product, causing unexpected impurities in stability studies and leading to time and resources consuming root cause analyses. Non-solid ophthalmic drug products are often solutions marketed in a LDPE bottle (e.g. droptainer), of which is it known that label migration cannot be excluded. In both the FDA and the EMEAGuidelines, the label is considered as part of the total container closure system and it should be verified that no contamination of the drug product is occurring from these label components. Toxikon Europe works with both the ophthalmic container manufacturers as well as with the pharmaceutical companies working in ophthalmic drug development. The services in testing ophthalmic CCS range from the typical compendial EP and USP testing up to a high level of Extractable/Leachable studies. Many companies in Europe have built a broad expertise in developing testing programs which require a combination of state-of-the-art analytical techniques, such as Headspace GC/MS, PTV-GC/MS, GC/MS, LC/MS, LC/MS/MS, ICP, IC... In addition, Toxikon Europe can offer it’s assistance in the elucidation of structural information for critical compounds, using GC-ToF, LC-ToF, FT-MS or NMR.