packaging solutions that improve time to market

Millstone Packaging Solutions: Increase speed to market and lower costs

Kelly Lucenti, President

Common Problems

Getting your product to market faster

Common Problems

• Packaging Development • Understanding different packaging configurations and the benefits, costs and

lead times associated with each • Selecting an appropriate sterile barrier • Validating the Design

• Validations • Determining necessary validations • Understanding the timeline associated with each validation type • Costs associated with each validation type • Re-executing if a validation fails; time and costs associated re-execution

Common Problems

• Inadequate resources

• Capabilities • Inspection requirements – people and equipment • Cleaning requirements / equipment • Assembly & packaging requirements / equipment

• People - not enough operators to support volume and lead time requirements

• Equipment

• Need more pouch or tray sealers • Need more inspection equipment • Technology is important for running efficient inspection cells & clean room spaces

• Capacity

• Not enough capacity to support the launch of new product lines • Not enough space for anticipated volumes

Common Problems

• Staying on top of industry standards

• Quality • Mixed product • Inadequate seals

• Lead Times • Launch deadlines • Validation lead times

Solutions

Prepare for successful & timely validations

Preparing for successful & timely validations

Choose the right packaging configuration • Understand how your device will be used in a clinical setting • Evaluate the benefits of different packaging options

Tray

Benefits: Compact Design, Space Preferred for Aseptic Transfer

Costs: More

Lead Times: Molding - 6 weeks Tray Sealing Fixture - 8 weeks

Pouch

Benefits: Cost Effective, Space Ability to Fit Multiple Designs

Costs: Less

Lead times: Die - 6 weeks

Figure 1

• Consider the “problem areas” associated with the device • Sharp edges, weight of implant – anything that could cause a failed validation • Incorporating tip protectors, mounting cards or tray inserts into your package design to protect

the implant

• What type of sterilization will be required? • Packaging systems must be designed accordingly • For example: EtO requires semi-permeable sterile barriers, allowing gas to enter the packaging

without creating a pressure differential that could lead to a burst or leak of the pouch/tray.

Being aware of all details can prevent significant delays during the validation process

Preparing for successful & timely validations

Determine what validations are required

Validation Documenting Procedures

• Installation Qualification (IQ): Objective Evidence that the manufacturing equipment is installed and connected to the appropriate utilities in accordance with its approved design criteria and the manufacturer’s specifications.

• Operational Qualification (OQ): Objective Evidence that the process equipment and ancillary systems, as defined in the Installation Qualification are capable of consistently operating within established limits and tolerances.

• Process Qualification (PQ): Objective evidence that the process is effective and reproducible and that the outcome produced meets all requirements for safety and efficacy.

ISO requires a methodical, documented process to detail the purpose, scope and procedure of each validation followed by a final report to document the results

Validation Types:

Sealer IQ Ensure sealer is installed

properly

Sealing OQ Develop sealing

parameters (min, nominal, max) and test at challenge

conditions

Sealing PQ Test nominal parameters for effective, reproducible

results

Distribution Testing PQ Test interaction between product & sterile barrier

Aging PQ Test the effect of aging on

sterile barrier

Sealing Validations

Determine what validations are required

Figure 2

Sealing Validations • What is an appropriate sample size?

Things to consider: the level of risk severity and probability associated with the given process. If a failure results in significant harm or damage, a larger sample size should be used to validate the process.

Bayes Success-Run Theorem – a typical method based on a binomial distribution that leads to a defined sample size.

Determine what validations are required

Figure 3

Sealing Validations • What tests should the samples be subjected to?

Things to consider when challenging a sterile barrier: • Qualitative techniques – seal integrity-visual inspection, bubble leak, dye penetration • Quantitative techniques – seal strength

Using these test methods, you can develop an acceptance criteria and begin executing. Understanding this beforehand will allow for a seamless transition between package design and validation execution.

Determine what validations are required

Distribution Testing & Aging Validations Validating the interaction between the product and the sterile barrier These validations must be performed at worst case conditions and should be subjected to qualitative and quantitative test methods.

Determine what validations are required

Consider Potential Failure Modes

Design Test

Figure 4

Determine what validations are required

Distribution Testing • Validates that the chosen sterile barrier is maintained during the shipping process

(according to ASTM D4169). • Involves packaging product into its final packaging configuration (sterile barrier,

unit cartons with IFUs, labels, etc.) and subjecting to a defined conditioning and distribution cycle.

It is vital to choose a suitable sterile barrier during the design stage to avoid failure during this validation step and prevent significant delays in the validation process. • Company example: Failed ship testing

Determine what validations are required

Aging Validations / Shelf Life Testing • Validates that the sterile barrier can be maintained through a given period of time which

provides an expiration date for the medical device (ASTM F1980). • Accelerated Aging manipulates humidity and temperature levels to hasten the testing

process and reach market faster. It is important to note that the ISO standard indicates that Real Time Aging is required to substantiate this data.

• To avoid potential issues with Accelerated Aging, be sure to check the pouch/tray supplier’s

suggested humidity and temperature levels. Exceeding these can yield negative results due to the extreme conditions.

• When testing, it is important to choose the part that has the greatest failure potential to the

sterile barrier, thus ensuring that the integrity of the sterile barrier is maintained when the product reaches market.

Key Takeaways A failure during these validations can create significant delays in reaching market; failure in the field leads to a recall, liability, and harm to the end-user. Re-execution of validations is costly.

Reviewing potential failure modes as well as the intricacies of these validations will provide a proper transition from the process validation stage to getting your product to market in a safe, effective manner.

Preparing for successful and timely validations

Stage 1

MMO Validation Flowchart

MMO Validation Flowchart

Stage 2

Solutions

Pre-validated packaging configurations

Pre-validated Packaging

One of the quickest, easiest, most cost-effective ways to get your medical device to market.

• Eliminates tooling & design costs • Packaging available in both tray and pouch configurations • Pre-validated to meet industry recognized standards • Compatible with various methods of sterilization • Reduces resource needs & costs • Increases speed to market (see validation timeline)

Solutions

Universal Packaging

Universal Packaging

One of the quickest, easiest, most cost-effective ways to get more of your products to market

• Single packaging configuration that accommodates hundreds to thousands of various sized implants

• Reduces validation costs and protocol development • Allows packaging across multiple product lines • Reduces “footprint” of packaging companies

Universal Packaging

Universal Packaging Option (Barger Packaging & Millstone) • Millstone teamed up with Barger and developed a special packaging that fits

roughly 80% of spinal and extremity implants • Double-sterile barrier thermoform tray with two polyurethane liners for

protection, inner and outer Tyvek lids and a shelf carton • The configuration can be sterilized by Gamma irradiation, EtO or e-beam The universal packaging solution is a flexible design that cuts down on validation costs as well as the validation timeline to release sterile packaged products to market. The packaging is an efficient design that fits the vast majority of spinal and extremities implants into a fairly small footprint.

Universal Packaging

Universal Packaging Option (Barger Packaging & Millstone)

Solutions

Outsource

When to Outsource vs. Package In-house

• Limited internal resources • People • Capacity • Equipment

• Tight deadlines

• Aggressive launch dates

• Quality • Specialized services catered to specific program and customer needs

• Cost Savings

• Experts that can do it better, quicker and for less overall cost

Evaluating a Packaging Partner

Four important considerations when evaluating a packaging partner: • Quality (Leadership) • Speed • Cost • Expertise

Evaluating a Packaging Partner

Quality:

• Perform a quality audit of the packaging facility • Evaluate company registrations & certifications • Class 10,000/ISO7-rated clean rooms • State of the art equipment and experienced operators • Evaluate company quality metrics; What are the company’s quality

standards and objectives? DPMO, 6 Sigma, FDA & BSI audit history, etc. • The best packaging facilities are run by experienced leaders, have skilled

operators and state-of-the-art facilities and equipment. • Core competency - Expertise

Evaluating a Packaging Partner

Speed:

• Evaluating average lead time for the production of finished goods (from vendor receipt to final sterilized shipment)

• Utilizing industry “best practices” to be more efficient. • Increasing through-put and speed to market as well as the ability to

effectively manage vendors are advantages.

Evaluating a Packaging Partner

Cost:

• Quality, speed, and cost are all interrelated. • Cost of internal clean room is related to expense of labor and

equipment as well as speed to market. • Reducing labor overhead, developing turn-key processes, validation

services • Outsourcing packaging requires giving up some control but can be

a cost-effective alternative that, with the right partner, can enhance quality.

How to Maximize Outsourcing Relationship

• The relationship needs to be a partnership where both companies mutually benefit

• Understand the company’s core competencies • Select a partner that can scale with the growth of your company and be able to

support future projects • Set up open communication between the two companies • Leverage partner’s experience and knowledge of best practices in the industry • Benefits include: Speed to market, access to expertise, enhanced quality,

reallocation of internal resources, and reduced costs

Q & A

Kelly Lucenti klucenti@millstonemedical.com 508.679.8384

Millstone