INTRODUCTION
The primary packaging is the first packaging that directly contacts the product. It has several essential functions, but the most important is to uphold the highest medical standards, maintain the integrity of the product and prevent the entry of micro-organisms, which enables the product to maintain sterility at the place of use.
MATERIALS USED FOR PACKAGING
The material and methods used in packaging are of vital importance. Most medical packaging uses polymer films as they are safe against contaminants and maintain product integrity. An important feature of medical polymer films is that it guards against light, inhibit or enable air circulation, and protect the equipment from moisture and other gases (1).
The packaging of disposable syringes needs to be opened without fiber tear and should be robust enough to withstand wear and tear on the edges (2). We are adept in producing high-quality, durable, and reliable medical equipment like disposable syringes and IV sets. The focus for every client while buying is usually a combination of safety efficacy and cost-effectiveness, and our focus is the safety and satisfaction of our end customer.
TYPES &FEATURES OF PRIMARY PACKAGING AVAILABLE
There are various types of packing available in the market, like form-fill-seal packaging made of medical paper, form-fill-seal packaging made of rigid medical film, form-fill-seal packaging made of grid-coated paper(3), etc. The standard solutions like:
Poly Ethylene Packing
This is a simple packing that facilitates easy opening and is cost-effective.
Blister Packing
- SOFT BLISTER PACKING – is a form-fill-seal packaging made of soft medical film. The advantage of this packaging is that the machines can be used with a high degree of automation, high efficiency, and low cost of individual packaging; however, the machine requires a significant investment, and the packaging cannot hold large-size products.
- HARD BLISTER PACKING – is a form-fill-seal packaging made of rigid medical film. Machines with low automation, low efficiency, and high cost of individual packaging can be used. The advantage is that the cost of the machine investment is small, and it can hold large-sized products.
Paper Pouch Packing
It is a form fill seal packaging made of medical paper. The advantage of this packaging is that it can be packed by hand. But can only be used for simple devices.
Transparent Poly Bag With Medical Belt
This packing helps the ethylene oxide to escape through the white paper backing of the packaging.
The source and traceability of all our materials, primarily recycled materials, are known and controlled to ensure that our finished product will consistently meet the requirements of the standard. The packaging system is designed to minimize the hazards and ensure safety to the user and patient under the intended specific conditions of use. The materials are chosen in such a way that they are compatible with the sterilization process and sterilizing agent.
The packaging material also ensures that there is no physical, chemical, or biological damage to the product. Also taken into consideration is the fact that the packaging material should be compatible with the condition during the opening of the packaging and removal of contents. The mandate is such that our company uses material that does not contain or release any toxic material in sufficient quantity to cause any health hazard.
Another feature of our packaging is its compatibility with the labeling. Our labeling is compatible with both packaging material and the sterilization process. We do not use any ink that is transferable to the medical device, nor does it react with the packaging material, which can, in turn, impair the utility of the packaging material or system.
STERILIZATION OF SYRINGES& IV SETS IN PACKAGING
The sterilization method used for disposable syringes& IV sets is ethylene oxide. The ethylene Oxide (EO) process is a low-temperature gaseous process widely used to sterilize a variety of healthcare products, such as single-use medical devices.
Ethylene oxide is an alkylating agent that disrupts the cellular metabolism and reproductive processes of microorganisms. EO penetrates breathable packaging, making contact with all accessible surfaces of the product to deliver the required sterility assurance level.
Materials sterilized with EO are not exposed to excessive heat, moisture, or radiation. Therefore, a wide variety of materials, particularly polymeric components commonly used in medical devices, can be sterilized with Ethylene oxide.
Another advantage of ethylene oxide sterilization is that the products can be sterilized in their final packaging since EO will permeate the sealed films and cartons used to package the device.
Our syringes contain a microbial barrier property, which is, it maintains sterility from sterilization until the point of use or until the expiry date.
MEDICAL PACKAGING STANDARDS
There are several codes in place to ensure the quality of medical packaging. Regulatory requirements are increasingly stringent throughout every step of a product, including service and delivery. Increasingly, organizations are required to show their quality management protocols and ensure that the best practices are maintained in everything we do.
We, as a manufacturer, abide by the ISO 13485 standard protocol to maintain the highest quality and integrity of our products.
The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavor. The device components and the packaging system should be combined to create a sterile medical device that performs efficiently, safely, and effectively in the hands of the user.
The goal of a terminally sterilized medical device packaging system is to allow sterilization, provide physical protection, maintain sterility up to the point of use, and allow aseptic presentation. The specific nature of the medical device, the intended sterilization methods(s), the intended use, expiry date, transport, and storage all influence the packaging system design and choice of materials.
The term “sterile barrier system” was introduced in ISO 11607-1:2006 to describe the minimum packaging required to perform the unique functions required of medical packaging: to allow sterilization, to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging” protects the sterile barrier system, and together they form the packaging system. “Preformed sterile barrier systems” would include any partially assembled sterile barrier systems such as pouches, header bags, or hospital packaging reels.
ISO 11607 is the medical device industry’s most widely used international standard for the packaging of medical devices. Adopting ISO 11607 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of the packaging of medical devices.
