Developing a domestic or commercial product in the pharmaceutical industry needs time and development. There can be many hurdles to navigate, certificates to obtain, and several testing and trials before product launch. These scenarios can take years to push through, but once you get to the end and have a final product that you can sell to consumers, it could be worth all the hard work.
As a packaging supply company, understanding medical administration equipment has been on our development schedule for some time. The areas of interest include;
- Dosing equipment (e.g., cups, eyedroppers, blunt syringes)
- Nasal sprays, inhalers
- Medication patches
- Test Kits
- Pregnancy test
- Male/female/stress hormone test
- Cholesterol test
- Allergy test
- Bladder infection test
- HIV test
- Hepatitis C test
- Drug, alcohol, nicotine test
- First Aid Equipment
- Ace bandage, compression stocking
- Snakebite kit
- Heating pad
- Ostomy care
- Tracheotomy care
As Raepak specialises in dispensing products, it was natural for our Product Development Team to start with dosing solutions. These include nasal spray pumps and spray pumps, both pharmaceutical grade.
*Pharmaceutical grade – These are raw materials that meet the pharmaceutical standards for manufacturing. They are highly pure and contain no binders, fillers, or other unknown substances.
Certification For Pharmacy Products
Once we understood our audience and product grade, we validated our offering with the correct credentials. Raepak’s range of pharmaceutical spray pumps and bottles have been manufactured for liquid medical products. The manufacturing process has been assessed by SGS and meets the requirements of ISO 15378: 2011. This works in conjunction with our primary packaging materials for medicinal products, which is a particular requirement for the application of ISO 9001:2008 with reference to good manufacturing practices (GMP).
*ISO 15378:2011 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.
ISO 15378:2011 is an application standard for designing, manufacturing, and supplying primary packaging materials for medicinal products. It is also applicable for certification purposes.
*ISO 9001:2008 specifies requirements for a quality management system where an organization;
- Needs to demonstrate its ability to consistently provide a product that meets customer and applicable statutory and regulatory requirements
- Aims to enhance customer satisfaction through the system’s effective application, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Pharmaceutical Packaging For Dispensing
Raepak has developed two pharmaceutical grade products to help with the different liquid products on the market.
Nasal Spray Sets
Pharmaceutical grade nasal spray sets with matching bottles. Perfect for medical, domestic or commercial applications. Two options available include the ratchet neck and the classic finish.
Pharmaceutical grade oral spray pumps with a ribbed collar design. Superior for medical, domestic or commercial applications. Both come with a transparent cap for re-usability.
As the UK leader for dispensing pumps, our Product Development Team took these product solutions to the next level. All our Pharmaceutical Grade Nasal Spray Pumps have three-chamber design options.
This dispensing pump design allows the liquid to touch the metal while being dispensed. This is fine for liquids that won’t erode standard grade 304 metal. We can use a better grade metal spring such as 316. However, the MOQ would have to be high for the product to be viable.
A metal spring in the dispensing pump’s actuator enables liquid to pass through the pump mechanism without touching the spring. However, some liquid products can be quite aggressive or abrasive to the metal spring. This can sometimes erode the spring and cause a break, discolour the liquid contents or cause an ugly rust effect inside the dispensing pump. This can be seen if using a transparent colour finish. This is why we offer a springless chamber. Liquid content high in salt or acid would best suit this type of design.
SPRINGLESS – NO BALL
A dispensing pump is made up using these components: Stem, Piston, Spring and Ball. These parts can vary based on the design of the pump. Some pumps have additional components that aid the product flow. Raepak offers the springless with no ball option. This makes sure no mechanism comes into contact with the liquid.
If you would like more information on our pharmaceutical dispensing options? Please read our brochure or contact one of our friendly Account Managers today.