Both rigid and soft contact lenses are subject to the regulations of medical and surgical devices with regard to hygiene and the way in which they are marketed – including packaging regulations – and to the materials used for their manufacture, which must be biocompatible.
Farmo Res produces machines for their packaging, often included in production lines that end, in most applications, with the marking of the packaging in which the lenses are inserted and sold.
Being a good used by many in their daily lives, we present in this article some of the rules that companies should respect in their production.
Almost all types of contact lenses, before being placed on the market, must obtain authorization from the “Ministry of Health – Directorate General of Pharmaceutical Service”.
The materials used to make contact lenses must be biocompatible. The relevant documentation must be submitted together with the applications for authorisation. For the plastic materials used in the manufacture of contact lenses, the chemical-physical characteristics of the material must be provided in order to be able to identify them. Contact lens manufacture should be carried out in hygienic environments.
Soft contact lenses should be placed on the market sterile, in suitable packaging, sealed and able to ensure the preservation of the condition of sterility and provide for the absence of residues of disinfectant solutions. Rigid and gas-permeable contact lenses must be placed on the market disinfected and with the microbiological requirements laid down by the F.U. IX edition for products that are not necessarily sterile, or by other Pharmacopoeia of another Member State of the EEC; they must also be placed on the market in suitable sealed packaging.
Each batch of lenses must have a production number. Each package shall specify: the type of material used for the manufacture of the lens, the date of manufacture and expiry.
Each company shall place the contact lenses on the market, accompanying the packaging with adequate information documentation containing information on the sterilization and disinfection process adopted, the initial general adaptation programme, the maintenance and disinfection system of the lens itself, its correct use, storage conditions and any contraindications.
The requirements for the evaluation of the products to be authorised concern:
- chemical composition of the material;
- chemical-physical stability;
- constancy of shape and elasticity characteristics;
- characteristics of transfer to the tear liquid;
- refractive indexes;
- optimal light transmission;
- mechanical resistance and ability to withstand appropriate disinfection and sterilization cycles;
- permeability for water-soluble metabolites and nutrients;
- possible gas permeability;
- indications about the possible properties of absorption towards the components of the solutions of conservation, cleaning and disinfection;
- composition of any humidification liquid;
- any other element useful for the evaluation of the characteristics of the product.
It is forbidden to recycle contact lenses returned from the market, for any reason, to interested companies and operators. It is only possible to use the lenses used for tests repeatedly, after further sterilization or disinfection.
Discover Blister Sealer, the machine for packing up to 7.200 contact lenses per hour
This is Farmo Res’s flagship contact lens packaging machine. Sold worldwide, it is available in 4 standard models, customizable according to every need. We are manufacturers! If you need to pack contact lenses or expand your production, call us at 0544-981900! If you want more details about the Blister Sealer machine or you want to see an example video of its operation, clic here