Mr. Pradeep Rao
Director
Pradeep Surgipack

Packaging used to pack medical devices which are to be sterilized.

Standards

EN 868 Part 1, 3, 5 & 6

Part 1 – Packaging materials and systems for medical devices which are to be sterilized
Part 3 – Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5)
Part 5 – Heat sealable pouches and reels of porous materials and plastic film construction
Part 6 - Paper for low temperature sterilization processes - Requirements and test methods

EN ISO 11607 Part 1 & 2

Part 1: Packaging for terminally sterilized medical devices : Requirements for materials, sterile barrier systems and packaging systems
Part 2: Validation requirements for forming, sealing and assembly processes

Presentation

1. Reels or pre-formed pouches

2. Paper Bags

3. Header Bags

Characteristics

1. Should be sealable and peelable

2. Should protect the device from dust, moisture and impurities

3. Should be sterilizable by the appropriate method and should maintain sterility for a sufficient period of time depending on the device, method of sterilization, storage & transportation

Construction of Reels / Packs

Hospital Flat Reels

1. Medical Grade Paper of 60gsm / 70gsm (conforming to EN 868 Part 1 & 3), sealed on to Bi-Laminate Film of Cast Polypropylene (CPP) and Polyester (PET) – Suitable for Steam or ETO Sterilization. Sterility Shelf life 6 months from date of sterilization

Pre-Formed Pouches – 3 –Side Sealed with “chevron” seal on one side

1. Medical Grade Paper of 60gsm / 70gsm (conforming to EN 868 Part 1 & 6), sealed on to Bi-Laminate Film of Polyester (PET) and Polyethylene (PE) – Suitable for ETO & Gamma Sterilization. Sterility Shelf life 3 years from date of sterilization. Not suitable for Steam Sterilization.

2. Grid Lacquered Paper sealed on to PE Film - Suitable for ETO & Gamma Sterilization. Sterility Shelf life 3 years from date of sterilization. Not suitable for Steam Sterilization. No Prevalent Standards

3. Grid Lacquered Paper sealed on to Laminated Poster Paper - Suitable for ETO & Gamma Sterilization. Sterility Shelf life 3 years from date of sterilization. Not suitable for Steam Sterilization. No Prevalent Standards

4. Poster Poly Pouches - Suitable for ETO & Gamma Sterilization. Sterility Shelf life 3 years from date of sterilization. Not suitable for Steam Sterilization. No Prevalent Standards

5. Uncoated Tyvek® sealed on to Special Bi-Laminate Film of Polyester (PET) and Polyethylene (PE) – Suitable for ETO, Gamma & Plasma Sterilization. Sterility Shelf life 3- 5 years from date of sterilization. Not suitable for Steam Sterilization. Grades of Tyvek include 1073B, 1059B and 2FS)

6. Coated Tyvek sealed on to Bi-Laminate Film of Polyester (PET) and Polyethylene (PE) – Suitable for ETO, Gamma & Plasma Sterilization. Sterility Shelf life 3- 5 years from date of sterilization. Not suitable for Steam Sterilization

Paper Bags

1. Made of 60 gsm medical grade paper with heat sealable glue. Used to pack very light devices like suture threads, surgical dressings etc.

2. Steam Sterilizable only

3. Sterility Shelf life not more than 3 months from date of sterilization

Header bags

1. Made of clear Low density Polyethylene (LDPE) or LDPE/EVA/PVA and a peelable strip of Coated Tyvek or Reinforced Coated Medical Grade Paper for aseptic opening of bags

2. Used to pack heavy or large Kits, Drape packs & Gowns

3. Preferable to sterilize by EO

Other Packaging

1. Aluminum Foil Packs

2. Blister Packs

3. Pre-formed Trays with Coated Tyvek Lids

Factors influencing choosing of suitable packaging

1. Nature of medical devices

2. Method of sterilization

3. Method of packing the device

4. Sealing techniques

5. Primary or secondary packaging

6. Storage Conditions & Transportation method

7. Presentation

8. Cost