NASP maintains a quality system that is in strict compliance to 21 CFR 820, ISO 13485 2003, ISO 11135: 2007 and other standards specific to Biological Indicators, Maintenance of a classified clean room, and Environmental and medical waste disposal regulations. We are FDA registered facility #2244478

Additionally, NASP customers often require compliance to specific internal needs. We have a strong system that will stand on its own, but our system is also capable of being modified, when necessary, to meet specific customer requirements. It is not unusual for NASP to adopt unique customer policies, tests or inspections at any point in the process

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Many or our customers come to NASP with labeling software already specified. We will use whatever software the customer requests but we have a wide range of internal capabilities.

All our software is validated and is subject to appropriate security measures. We have Multi color label, graphics, and bar code capabilities

We can produce your labeling in a secured label room or we can install label production onto the production floor at point of use if it makes sense and is acceptable to the customer.

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New applications may be seamlessly integrated into current processes or we can develop new processes for individual customer designs. We can input individual labels where changes are infrequent or work with large databases for large product lines

Validation is the documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications (ANSI/AAMI/ISO 11135-1). Validation of the EO sterilization process yields a documented procedure of consistently confirming the inactivation of all living microorganisms, confirmation that the product or device is sterile, and confirmation that the process is repeatable.

NASP offers a full range of validation services and will assist customers to whatever degree is necessary. We can make recommendations, write protocols, run the validations and write the reports. Documentation of all validations remain at NASP permanently.

Validating a cycle for routine use is a time consuming process. When performing the validation of a sterilization process you must perform an Installation Qualification, an Operational Qualification and a Performance Qualification.

An installation qualification (IQ) is the process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification.

An operational qualification (OQ) is the process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures.

Performance qualification (PQ) is the process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification. (ANSI/AAMI/ISO 11135-1)

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Basically with an IQ we demonstrate that we have installed the sterilization equipment and any ancillary items in accordance with their supplier specification, with an OQ we demonstrate that the installed equipment is operational according to its intended use, with a PQ we demonstrate using product, that the installed equipment is operates consistently and performs according to your intended use producing product that is sterile.
With most industrial sterilizers, the IQ and OQ are typically already done unless there is a change to any equipment. Rather, commissioning, which is the verification that the equipment is operating as required, is performed on an annual basis. The PQ however is the part of the process that must be performed to qualify a new product, a new cycle, or introduce a change to products, packaging, etc unless adoption or equivalence to an already validated product can be demonstrated. Once the performance qualification is completed, the process may be run routinely.

AAMI/ANSI/ISO 11135-1 Sterilization of healthcare products – Ethylene Oxide –Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices is the standard that must be followed for validating a sterilization process. The most common method of performing the performance qualification is to follow the half cycle “overkill” method. This is demonstrated by performing one sub-lethal cycle, three half cycles, and three full cycles. The purpose of the half cycle “overkill” method is to demonstrate a 6 log spore reduction at half the time of the proposed routine cycle, therefore stating that at the proposed routine exposure, the biological indicator will be reduced to a 12 log spore reduction.

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The biological indicator (BI), often referred to as the process challenge device (PCD) is the test system which contains viable microorganisms given a defined resistance to specific sterilization processes. For EO sterilization the biological indicator most commonly used is a 106 spore of Bacillus Atrophaeus, which is the most resistant microorganism known to EO sterilization. When these microorganisms are exposed to enough ethylene oxide they are killed. When you expose a 106 BI to the half time sterilization cycle and it tests negative it has now been reduced by a 6 log spore reduction to 100. Because microorganism death is logarithmic this will confirm a 12 log spore reduction at the routine time.
The science behind this is that when you spore a load with BIs that are 106 or 1,000,000 microorganisms, expose it to a sterilization process, and test it at the lab; if the BI’s are all negative you have reduced the microorganisms from 106 to 100 at a minimum. This method therefore demonstrates that at twice the half time, or the proposed routine time, you will then reduce the BI by another 6 log spore reduction down to 10-6.

All of this is verified during the performance qualification which consists of 2 main steps, the physical qualification and the microbiological qualification. The physical qualification requires three consecutive runs to demonstrate the reproducibility of the process and that the acceptance criteria are met throughout the load for the durations of the proposed routine process. It confirms that the process is operating within the required parameters and the load is reacting properly. This is confirmed by reading the load sheets which are produced by the sterilization equipment and by using sensors. The loads must contain the proper amount of temperature sensors and humidity sensors. The required amount is based on the volume of the product load.

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The microbiological PQ shall demonstrate that when exposed to the sterilization process the requirements for sterility are met. The load shall be representative of the most challenging to sterilize routine load. This is demonstrated using the biological testing previously described. This is confirmed using biological indicators. The required amount is based on the volume of the product load. In addition to the biological indicators, several other microbiological testing is required. The validation process is broken up into three loads. The first load consists of a sub-lethal cycle, half cycle and full cycle. The second and third loads consists of each a half cycle and full cycle.

For each load of three separate lots bioburden testing must be performed. Bioburden is the natural level of microorganisms that are on a product or device. This testing ensures that the product bioburden is consistent and does not contain more microorganisms that the intended PCD. This is done pre-sterilization. Bacteriostasis and fungistasis must be performed following sterilization for one load to confirm that the product has no bacteriostatic or fungistatic properties which might interfere with the test results. Product sterility testing must be performed following each of the sub-lethal and half cycles to confirm the sterility assurance level has been met.

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There are two types of BI/PCDs used, internal and external. Internal PCDs are placed in the hardest to sterilize positions of the device and external PCDs are placed externally to the load and will be used to monitor routine processes. When performing a sub-lethal cycle you are looking for partial positives and partial negatives. What this means is that you want the product sterility and internal BI/PCDs to be all negative but want the external BI/PCDs biological indicators to have a mix of positive and negative. This confirms that the product is less resistant to the sterilization process than the PCD.

With a half cycle you want everything to be negative, both products and internal and external PCDs. This demonstrates the 6 log spore reduction. The full cycle is more representative of the routine load therefore it has limited microbiological testing. The full cycles require external PCDs which must all be negative, and samples for residue testing. Ethylene oxide sterilization often leaves EO residua and ethylene chlorohydrin residues. Samples must be tested to detect the levels of patient exposure. All samples must be compliant with the most recent version of ANSI/AAMI/ISO 10993-7 entitled, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals.

After the microbiological and physical PQs have been completed a report is generated to present all of the data. The process is then considered qualified and may begin to be used for routine sterilization. Although the cycle has been qualified, it is recommended by AAMI that a requalification be performed annual and consist of at a minimum a documented review of all applicable processes to verify that nothing has changed that would affect the process. It is recommended that a revalidation study using a minimum of a 1 half-exposure cycle run at minimum conditions be performed at least every two years. In case of significant changes, the appropriateness of the revalidation time and criteria will be evaluated.

NASP is a contract packager first and foremost. We have been packaging medical devices for close to two decades. We operate over a wide range of package types, processes, and product volumes.

• Some of our customers have relatively simple products that involve very basic operations, but some are quite complex. We have products that consist of hundreds of parts with very complicated sub-assemblies.
• We also have customers with lot sizes of six (6) units, but who require many lots each month.
• We have products with extensive component lot traceability requirements and complicated expiration dating requirements.

It is difficult to categorize a “Typical” NASP packaging project. Every job tends to be unique and has necessitated the ability to be nimble and creative. Whatever your particular needs, we have probably done something similar to it.

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NASP maintains an engineering lab with capabilities to characterize materials and help our customers develop products, make changes, and trouble shoot problems.

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NASP can easily help our customers because we are present at the point of production or receipt of components and have direct contact with the suppliers of the components. We often act as an extension of quality or design teams.

The NASP customer base is quite varied and every customer has unique needs and issues. NASP has become a specialist in accommodating these specific customer needs.

Customer documents are received and incorporated into the NASP system in a well-controlled manner, providing revision control and customer approval and accountability

Device Master Records for each customer are maintained and may contain any level of detail that is appropriate

Device History records for every lot are generated through the manufacturing process. All in process steps are recorded and tracked and become part of the permanent record. There is a built in system for continuous checking, resulting in error free documentation.

Full traceability of components is maintained

Final release package tailored to specific customer requirements. This “Packet” may be as simple as a single Cert up to a full package with production data and actual label samples.

Incorporation of bar code scanning technology to reduce potential for errors

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NASP uses a wide range of tools for inspection including OGP vision system, various force gauges, burst test and peel test equipment, flow rate instruments and pressure testing equipment. Our inspection systems can be as complex or as simple as your product demands.

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We can use this equipment to provide ongoing production support as well as supporting your design efforts. We can help your quality team in troubleshooting problems or your design team in developing product changes.

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We treat each project as a unique opportunity and will procure whatever equipment or instrumentation is necessary to accurately and completely meet the test requirements of our customers.

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Many of our customers require 100% testing of critical assemblies. Assembly integrity, pressure integrity, electrical performance, torque, or special visual characteristics all have been subject to in-process 100% testing. We will work with your technical team to provide all adequate testing as well as develop data to eliminate testing where and when appropriate.

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NASP maintains capabilities to perform inspections over a wide range of customer needs. We have the ability to provide detailed measurement & analysis of parts or we can work with your vendors to accept parts in accordance with your individual requirements. Our customers have quite varied requirements and NASP has developed the capability to meet all of them.

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As a contract manufacturer, NASP must meet the individual needs of a varied customer base. Our quality systems are complete, robust and available for use by all our customers. However, we are often required to provide additional procedures or special case activities that require us to modify these procedures to meet special customer needs. If your quality system requires the use of specific forms, procedures, tables, reports, limit samples, or any other unique documentation, NASP is well equipped and willing to accommodate these requirements. These are typical requirements for us.

Every product is unique and even though the item may be similar to others, we have learned that care taken at the outset of a product design cycle, will ultimately result in a package that works. NASP currently provides packages in a wide range of formats and we have had experience with even more over the years.

This allows us to draw on a wealth of experience and may result in ideas that are not evident at the outset.

We can help you with your package design and we can help you with the testing and validation of that package.