Pharma PET bottles
Veral and Syrup bottles for the Pharma Range
Frapak/FlexPET have carefully manufactured two ranges of Pharmaceutical PET bottles, Veral and Syrup shaped, specifically for (OTC) ‘over the counter’ products and prescription medications sold through drugstores and pharmacists.
The bottles are provided with a 28 ROPP (Roll on Pilfer Proof) neck finish which can take various Tamper Evident Caps (TE-closure) and even the official ISO 8317 certified TE - CRC closure.
A wide range of sizes of the Veral and Syrup bottles, in CLEAR and AMBER, are available in stock with a (MOQ) ‘minimum order quantity’ of 1 pallet.
Pharmacopoeia-approved raw material
Our high-end Pharmaceutical PET products are made from the highest possible grade of PET material which is European Pharmacopeia approved.
The material RamaPET R180 from the manufacturer, Indorama, is produced in the Netherlands at their Rotterdam plant and has been certified to be compliant with the European Pharmacopoeia since the mid-90s.
Cleanroom production environment for the Pharma PET bottles
Frapak/FlexPET produce the Veral and Syrup Pharmaceutical PET bottles under strictly controlled conditions in an ISO Class 7 cleanroom.
In the cleanroom, the area where the product is physically made and transported, conditions have even been boosted to an ISO Class 8 level.
Clean packaging of the products
The products coming into the cleanroom are produced and packed without any contact by human hand.
All the bottles and jars in the cleanroom are automatically and directly packed into brickpacks which guarantee a first layer of protection and a dust free cover.
Certified production procedures
Production at the manufacturing site, is done under strict quality procedures according to ISO 15378:2011, a standard which certifies a quality system, including GMP (Good Manufacturing Practice), for the design and manufacturing of primary packaging materials for medicinal products.
Besides ISO 15378 the manufacturing site also carries an ISO 9001 and EN 15593 certificate all audited by TÜV Rheinland.
Migration testing of all the PET grades used by Frapak/FlexPET has been completed according to the latest EU regulation EC:10/2011.
DoCs (Documents of Compliance) are readily available and detailed migration reports can be shared under a non-disclosure agreement.
Although our products are sterile when they come out of the
machine, a higher level of guaranteed sterilisation can be met by using Gamma Irradiation. All the products which need to be gamma irradiated are put in brickpacks with 1 or 2 additional bags before being placed into the box pallet. At the gamma irradiation plant, the pallets are guided past a radioactive Cobalt 60 source emitting gamma irradiation which penetrates through the whole pallet including the brickpacks containing the PET products, thus guaranteeing a high level of sterility. Gamma-irradiation doesn’t change the technical properties of the products
and is known to be a very safe way of sterilising products without applying heat.