Medical Plastic Data Service Magazine



Our 28th Year of Publication
Page  2 of 11

Cover Story

Salient Aspects of Medical Device Packaging


Dr. R. Rangaprasad
Business Head
Packaging 360

Definition of a Medical Device

The Global Harmonization Task Force (GHTF) has proposed the following harmonized definition of a medical device:

Any instrument, apparatus, implement, machine, appliance, implant in vitro reagent or calibrator, software, material, or other similar or related article.

Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of :

  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease.

  • Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury.

  • Investigation, replacement, modification, or support of the anatomy or of a physiological process.

  • Supporting or sustaining life.

  • Control of contraception.

  • Disinfection of medical devices.

  • Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body, and

B. Which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means.


By definition, devices are involved in many different aspects of healthcare. As such, devices, their manufacturing processes, and the packaging that contains and protects them are extremely disparate. Complicated capital equipment, such as MRI tunnels and X-ray machines, are medical devices, but so are simple, commodity-like items such as tongue depressors and syringes. Some are meant for mass markets; others are niche items. Some are packaged individually; others are packaged in boxes of 100 s or 1000 s. Some are reprocessed, others are disposable, and some are used for a lifetime. Risks associated with device misuse and failures are equally varied, ranging from inconvenience to patient death.


Classification of Medical Devices


The great variation present in the medical device industry means that devices can be classified in a number of ways.


Devices can be categorized by :

  • The risk associated with improper use or a failure (generally high, moderate, and low).

  • Conditions of processing (reusable, disposable, capital equipment, etc.).

  • Conditions of the therapy (invasive, noninvasive).

  • Conditions of shipping and handling (capital equipment, commodity surgical, etc.).

Because the goal of these therapies is to maximize efficacy and protect patient safety, the most common way to classify devices is based on risk.


Key Considerations for The Development of Medical Device Packaging.


In addition to the normal functions of a packaging system, the following requirements are unique to Medical Devices.


Sterile Barrier System


The vital importance of maintenance of the sterile barrier system (SBS) is a distinctive characteristic of medical device packaging. Medical device packaging for disposables must not only maintain the SBS but, in many cases, also facilitate the sterilization of the device within. Such protective characteristics can be achieved  through the package shape, particularly in thermoformed parts, in order to avoid product shifting or to keep kit components separated or nested. For sealed packages, seal integrity is an important characteristic in product protection. Seals must be free of channels and must withstand the rigors of sterilization and transit.




Utility is related to the ease of use of the system. For many medical devices, quick and easy opening and removal of contents are crucial. While this consideration is also important for devices with relatively low risk, such as an adhesive bandage, it is extremely critical for sterile medical devices that are used in surgical arenas where the packaging must allow the device to be removed without contamination. This particular need has led to the development of special materials and sealants that, when used in combination, can provide package strengths that are adequate to endure the severity of processing and, at the same time, can be manually opened without imposing excessive stress on product or user.

Advertisers' Index

Accuprec Research Labs Pvt. Ltd., India
Ambica Medicare Engineering, India
Nu-Vu Conair Pvt. Ltd., India
Divya Steri Solutions Pvt. Ltd., India
ET Elastomer Technik, Germany
Eewa Engineering Co. Pvt. Ltd., India
Ineos Styrolution India Ltd., India
I-Kare Polyalloys Pvt. Ltd., India
KLJ Group, India
Lubrizol Advanced Materials India Pvt. Ltd.
Kuraray India Pvt. Ltd., India
Maider Medical Industry Equipment Ltd.China
Medicall 2019, India
Ferromatik Milacron India Pvt. Ltd., India
GLR Laboratories Pvt. Ltd., India
Pashiba Lifescience, India
Plastivision India
Pradeep Surgipack, India
PVC Colouring Compounding & Processing, India
Qosina, USA
Raumedic AG
SMC Medical Manufacturing Pvt. Ltd., India
Sterimed Medical Devices (P) Ltd., India
Steri Techno Fab, India
Tekni-Plex India Pvt. Ltd., India
Twist Engineering Works,India
Yuhuan Shengjiu Mould Co., Ltd., China

Airways Surgical Pvt. Ltd., India

Alpha Medicare and Devices Ltd., India
Alpha Therapeutics Pvt. Ltd., India
Ami Polymer Pvt. Ltd., India
Angiplast Pvt. Ltd., India
Appasamy Associates, India
Beacon Plastics, India
Delux Surgical, Inida
Ignisol Mediplas Corporation, India
Jain Rubbers Pvt. Ltd., India
Operon Strategist, India
R.R. Patel Gases (P) Ltd., India

Proven Trade Contacts, India

Sanidhya Enterprise, India
Surgi Pack India Pvt. Ltd.
Unikal Consultants, India
Vinit Performance Polymers Pvt. Ltd., India
Aircity, India
Amigo Surgi Care Pvt. Ltd., India
Angel Products, India
Apex Medical Devices, India
Jimit Medico Surgicals Pvt. Ltd.
Kavya Packaging, India
Life-O-Line Technologist, India
Mesco Surgical, India
Morrisons Lifecare Pvt. Ltd., India
National Healthcare, India
Pharmadocx, Inida
S. Nath & Co., India
Unikal Consultants, India
Venus Industries,India, Mobile : 9825747495
Zinkal Products, India
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