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This document becomes invalid when printed or filed in any place other than the original storage location. Each user must ensure to work only with the currently valid revision of this document!

410.06 Checklist for auditing sterilization

This document becomes invalid when printed or filed in any place other than the original storage

with radiation according to DIN EN ISO 111371:2006 Device:

Ref:

Date:

Manufacturer:

 

Auditor:

Name

 

Signature

 
  • 1. Scope

This checklist is applicable for sterilization procedures with irradiators making use of the radionu- clide’s 60 Co and 137 Cs, or generating accelerated electrons, or generating X-rays by accelerating elec- trons. Compared with the previous version, EN 552, the scope of ISO 11137-1 has been modified to accommodate requirements for the design of sterilization methods. The particulars with respect to the determination of the sterilization dose rate as well as dosimetry and dose rate measurement have been cancelled and are now accommodated in ISO 11137-2 and ISO 11137-3 respectively.

This checklist shall be used for assessment of operators of the corresponding sterilization facilities.

Where sterile products are to be included in the company’s product spectrum, a sterilization assess- ment (including assessment of design and validation of sterilization processes) must be carried out based on at least one product file of a sterile product. For sterile products of risk class III, the docu- mentation of design and validation must be examined.

Where an assessment of sterilization procedures validation is necessary as a part of the QM assess- ment for medical products, the present checklist should be applied in case of radiation used as the sterilizing agent.

  • 2. Responsibilities and authority Lead Auditor

The lead auditor is responsible for the examination and evaluation of the QM system in respect of the customer’s system documentation, the related standards and the ruling according to ISO 13485 and/or the Council Directive 93/42/EWG.

He is responsible for the work of the audit team and for the observance of the DQS processes. In case where the lead auditor is not a technical expert himself, he should accept the evaluation of the sterilization validation by the technical expert without any protest.

Technical expert

The expert is responsible for the competent evaluation of the aspects of the QM system that are spe- cific for a product or a procedure. The assessment of the design documentation, especially those parts specifying the design and validation of sterilization procedures, is his essential task.

  • 3. Approach to the evaluation

The goal of the assessment is to examine whether the requirements of ISO 11137-1 are fulfilled, or the satisfactory sterilization with radiation is evidenced in any other way. Any alternatively allowed procedure designated as such by the ISO 11137-1 shall be accepted.

The present checklist must be used as an instrument for the assessment.

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410.06 Checklist for auditing sterilization

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The assessment results must be formulated in the audit report, where a reference to this checklist can be made.

  • 4. Further applicable documents

Technical file review Assessment guideline

DIN EN ISO 11137-1 — Sterilization of health care products - Radiation - Requirements for design, validation and routine control of a sterilization process for medical devices and other further applicable standards referenced.

  • 5. Application of the assessment checklist

The checklist serves for the evaluation of audit results. Every audit requirement should be evaluated separately.

The evaluation of the documentation and implementation of a standard’s requirement should be documented in the column “Evaluation” in the following way:

  • 1 = fulfilled

  • 2 = partially fulfilled, still acceptable

  • 3 = partially fulfilled, not acceptable

  • 4 = not fulfilled na = not applicable

The numbering of the questions corresponds to the numbers of the requirements as printed in ISO

11137-1.

  • 6. Audit protocol

Please use the DQS form “Findings“ (“Feststellungen“). The findings must contain a reference to the checklist questions. These can be entered in the column “Reference” (“Referenz”). Please use the numbering system of the standard using at least two digits of the requirement’s number (e.g. 4.2 for “Management Responsibility” associated with ISO 11137-1). Additional evidence, such as copies of manufacturer’s documentation, should be ordered clearly (e.g. using the numbers).

  • 7. Abbreviations

SAL

Sterility assurance level

IQ

Installation qualification

OQ

Operation qualification

PQ

Performance qualification

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4

Quality management systems

4.1

Documentation

4.1.1

Have procedures for the design, validation, routine control and product release from ster- ilization been specified?

 

4.1.2

Are all documents and records that are necessary according to ISO 11137-1 reviewed, approved and controlled*) by the designated personnel (see 4.2.1)?

 

4.2

Management responsibility

4.2.1

Are responsibilities and authorities for all the requirements of ISO 11137-1 specified and assigned*) to qualified persons?

 

4.2.2

Is there a contract agreement about the responsibilities and authorities, in case several organizations (with separate quality management systems) are involved?

 

4.3

Product realization

4.3.1-

Are procedures for purchasing, identification*) and traceability*) specified?

 

4.3.2

4.3.3

Is a system for calibration of all equipment and testing instruments specified**)?

 

4.3.4

Is the metrological aspect of the dosimetry traceable to national or international standards and is it of a known degree of measurement uncertainty?

 

4.4

Measurement, analysis and improvement — Control of nonconforming product

4.4

Are procedures for the control of nonconforming products, corrections, corrective actions and preventive actions specified*)?

 

*) respective applicable parts of ISO 13485 **) respective applicable parts of ISO 13485 or ISO 10012-1

5

5.1

Sterilizing agent characterization

Sterilizing agent

5.1.1

Has the type of radiation to be used been specified?

 

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5.1.2

For electrons or X-rays: has the energy of electrons been specified?

 

Is the electron beam energy >10 MeV (accelerated electrons) resp. >5 MeV (X-Rays)? If yes, is there a documented assessment of the potential for induced radioactivity in the product? (Section 8)

 

5.2

Microbicidal effectiveness

(No normative requirements)

5.2

5.3

Material effects

(Assessment of the effects on the product according to Section 8.1)

5.3

5.4

Environmental considerations

5.4

Are there, in the context of carrying out radiation sterilization procedures,

 
  • documented evaluations of possible environmental effects and impacts?

  • specified actions for environmental protection?

  • specified and implemented measures for monitoring (if identified)?

  • 6 Process and equipment characteristics

6.1

Process

6.1

Have process variables been defined and means for monitoring and controlling them been determined?

 

6.2

Equipment

6.2.1

Has the irradiator and its mode of operation been specified? If necessary, has the specifi- cation of the irradiator been revised (see 12.5.1) and retained for its life cycle?

 

6.2.2

Is the software used for controlling and monitoring the process developed according to a quality management system providing documented evidence that the software conforms to its design intention?

 

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ation

6.2.3-

Does the technical documentation, according to the type of the irradiator, describe the

NOTE: the required aspects depending on the respective radiation facilities are indicated in the fol-

 

6.2.5

following aspects?

lowing table with the number of the respective standard’s requirement.

Aspects

 

Type of irradiator

 
Aspects Type of irradiator



Electron

X-Rays

Radia-

beam

 

tion

 

generator

  • the irradiator and it’s specifications

6.2.3

a)

6.2.4

a)

6.2.5

a)

 
  • the activity, type of radionuclide and its activity, the geome- try of the -radiation source

6.2.3

b)

n.

a.

n.

a.

 
  • the characteristics of the beam (electron energy/energy of X-rays and, if applicable, average beam current, scan width and scan uniformity)

n.

a.

6.2.4

b)

6.2.5

b)

 
  • Dimensions, materials and construction of the X-ray con- verter

n.

a.

n.

a.

6.2.5

c)

 
  • The premises including the location of the irradiator

6.2.3

c)

6.2.4

c)

6.2.5

d)

 
  • Means for segregation of irradiated products from non- irradiated products (10.3, 10.4)

6.2.3

d)

6.2.4

d)

6.2.5

e)

 
  • The construction and mode of operation of each relevant conveyor system

6.2.3

e)

6.2.4

e)

6.2.5

f)

 
  • The conveyor paths and range of conveyor speed

6.2.3

f)

6.2.4

f)

6.2.5

g)

 
  • Dimensions, materials and construction of irradiation con- tainers

6.2.3

g)

6.2.4

g)

6.2.5

h)

 
  • The method of operation and maintenance of the irradiator and every relevant conveyor system

6.2.3

h)

6.2.4

h)

6.2.5

i)

 
  • The means for indicating the position of the -radiation source

6.2.3

i)

n.

a.

n.

a.

 
  • Means of indicating that the electron beam and conveyor system are operating

n.

a.

6.2.4

i)

6.2.5

j)

 
  • Means for automatically returning the -radiation source to its storage location and for automatically ceasing conveyor movement in case of a failure of the timer for the process control, or of the conveyor system

6.2.3

j)

n.

a.

n.

a.

 

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  • Means for halting irradiation in case of a failure of the con- veyor system which affects the radiation dose.

  • n. j)

a.

  • 6.2.4 k)

6.2.5

 
  • Means for automatically returning the -radiation source to its storage location and for automatically halting transport by conveyor or for detection of impacted products, in case the -radiation source is not at its desired position.

6.2.3 k)

n. a.

n. a.

 
  • Means for automatically halting transport by conveyor or for detection of impacted products, in case of failure of the electron beam.

  • n. k)

a.

  • 6.2.4 l)

6.2.5

 
  • 7 Product definition

7.1-7.2

Is the product to be sterilized, including packaging materials and modifications (12.5.2) to the product, its packaging or configuration within the packaging specified?

 

7.3

Is there a system for monitoring the condition of the products (including their bioburden) intended for sterilization such that the effectiveness of the sterilization process is not com- promised? Is the effectiveness of this process demonstrated and does it include the de- termination of the bioburden according to 11737-1?

 

7.4

If the sterilization dose for a product family is established, are the requirements of 11737- 2:2005, Clause 4, for the definition “product family” satisfied?

 

7.5

If a processing category is defined for the purpose of routine processing, have criteria for assessment as to whether it is to be included in a processing category been documented? Have product-related variables affecting the radiation dose and product-related parame- ters for processing been taken into consideration? Are there documented records of these assessments (see 4.1.2)?

 

7.6

Are there periodic documented reviews of the criteria for the inclusion of products or prod- uct groups in processing categories? Are the results of these reviews recorded (see

 

4.1.2)?

Evalu-

ation

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  • 8 Process definition

    • 8.1 Establishing the maximum acceptable dose

    • 8.2 Establishing the sterilization dose

    • 8.3 Specifying the sterilization doze and the maximum acceptable dose

8.1.1,

Have the maximum acceptable dose and the sterilization dose for the product been estab-

 

8.2.1,

8.3

lished? Does the product meet its specified functional requirements after treatment with the maximum acceptable dose throughout its defined lifetime?

8.1.2,

Have the following aspects been incorporated into the basic technical requirements for the

determination of the maximum acceptable dose and the sterilization dose?

 

8.2.3

NOTE: the required aspects regarding the dose are indicated in the following table by the number of the respective norm requirement.

Aspects

Maximum

Sterilization

Aspects Maximum Sterilization

acceptable

dose

 

dose

  • A facility capable of assessing the product with respect to its intended function

  • 8.1.2 a)

n. a.

 
  • A competent microbiological laboratory for the processes of determining bioburden according to ISO 11737-1 and sterility tests according to ISO 11137-2?

n. a.

  • 8.2.3 a)

 
  • A product representative of that to be produced routinely

  • 8.1.2 b)

  • 8.2.3 b)

 
  • A suitable radiation source that is capable of precisely and exactly emitting the required dose (see 8.4.1)

  • 8.1.2 c)

  • 8.2.3 c)

 

8.2.2

Is one of the following procedures used to determine the sterilization dose:

   
  • a) Knowledge of number / radiation resistance of the bioburden is acquired and used (ISO 11137-2:2006, 6.1)?

  • b) Establishing a dose of 25 kGy or 15 kGy respectively and confirmation (by evidence available to the primary manufacturer) that this dose fulfils the specified requirements for sterility (ISO 11137-2:2006, 6.2)?

  • 8.4 Transference of maximum acceptable, verification or sterilization dose between radiation sources

8.4.1

Should the maximum acceptable dose be transferred to another radiation source, is a documented evaluation carried out to prove that the validity of the dose is not impacted? Are there records of the evaluation results (see 4.1.2)?

 

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8.4.2ff

During the transfer of the verification or sterilization dose, is it controlled that one of the following conditions is fulfilled?

 
  • a) There was evidentiary data proving that changes in the usage conditions of the two radiation sources had no effect on the effectiveness of sterilization.

  • b) The dose transfer took place between

  • a -irradiator and another -irradiator, or

  • one electron beam generator and another electron beam generator, or

  • one X-ray generator and another X-ray generator

  • For products containing water in the liquid state, dose transfer is only permitted between two radiation sources (electron beam, X-ray) operating under identical conditions or two -irradiators.

9

Validation

9.1

Installation qualification (IQ)

9.1.1

Have operating procedures for the irradiator and each associated conveyor system been specified?

 

9.1.2

Is a documented verification of the procedure and auxiliary materials including software carried out with respect to operations within the design specifications? Are the results re- corded (see 4.1.2)?

 
 

Are the following aspects determined, documented and recorded (see 4.1.2)?

9.1.3

  • any modifications made to the irradiator during installation (6.2.1)?

 

9.1.4

  • for -irradiators - activity of the source, description of the positions of individual com- ponents of radiation source?

 

9.1.5-

  • for electron beam generators and X-ray generators — characteristics of radiation

 

9.1.6

(electron or X-ray energy, average beam current and, if applicable, scan width and scan uniformity)?

9.2

Operational qualification (OQ)

9.2.1

Is the calibration of all measurement and test instruments confirmed before OQ? (see

 

4.3.3)

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9.2.2

Is the OQ carried out by irradiating homogenous material representative of the product to be processed? Are the operational abilities and adequacy of the irradiator adequately demonstrated defined specified acceptance criteria (Section 8)?

 

9.2.3-

Is dose mapping carried out correctly within material containers as well as within fully

 

9.2.4

loaded irradiators (using suitable dosimeters and sufficient measurement points for effec- tive reproducibility)? (ISO 11137-3)

9.2.5

Is dose mapping carried out on a sufficient number of irradiation containers to allow to determine the dose variability and distribution between the containers?

 

9.2.6

Is the dose mapping carried out for each conveyor path used to process product?

 

9.2.7

Are the effects of an interruption of the process on the dose determined and recorded?

 

9.2.8

Do the records of dose mapping include the following: Description of the irradiation con- tainers, operating conditions, used materials, dose measurement, conclusions?

 

9.2.9

For facilities: Is the relationship between timer settings, the speed of the conveyor sys- tem and the dose determined?

 

9.2.10

For electron beam and X-ray irradiators: During dose mapping, do the fluctuations in ra- diation characteristics (see 9.1.5, 9.1.6) lie within the limiting values according to the irra- diator specifications (see 6.2.4, 6.2.5)?

 

9.2.11

For electron beam and X-ray irradiators: Is the relationship between beam characteristics (see 9.1.5, 9.1.6), speed of the conveyor system and the dose determined?

 
  • 9.3 Performance qualification (PQ)

9.3.1

Is dose mapping carried out using a product loaded in irradiation containers according to a specified loading pattern, so that the following can be identified / determined?

  • a) Location and magnitude of minimum and maximum dose

 
  • b) The relationships between the minimum / maximum dose and the dose(s) at the rou- tine monitoring point(s)

 

9.3.2

Is the manner of presenting product for sterilization specified, with inclusion of

  • a) Dimension and density of the packaged product?

 
  • b) Orientation of the product within the packaging?

 
  • c) Description of the irradiation containers (in case multiple types are used)?

 

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d)

Description of the conveyor paths (in case multiple conveyor paths are used within the irradiator)?

 

9.3.3

Is dose mapping carried out for every processing class (7.5)?

 

9.3.4

If partially filled irradiation containers are used during routine processing, is the effect of partial filling on dose distribution within irradiation containers as well as on other contain- ers present within the irradiator determined and recorded (see 4.1.2)?

 

9.3.5

Are the irradiation containers used for dose mapping representative and sufficient for the determination of dose fluctuations between containers?

 

9.3.6

Is dose mapping carried out for each conveyor path used for processing the defined prod- uct?

 

9.3.7

For - and X-ray irradiators: is dose mapping carried out to identify products (or, if used, processing categories) that can be processed with the product being mapped? Are the effects of the dose on products of different densities determined to define products that can be processed together?

 

9.3.8

Are the following aspects included in the records for dose mapping: description of irradia- tion containers, loading patterns, conveyor path, irradiator operating conditions, dose measurement, conclusions?

 
  • 9.4 Inspection and approval of validation

9.4.1-

Is the information generated during IQ, OQ and PQ reviewed and the outcome of this re-

view recorded and used as a basis for the process specification? (see 4.1.2)

 

9.4.2

9.4.3-

Does the process specification for the respective type of irradiator contain details to the

following aspects:

 

9.4.4

NOTE: The required aspects depending on the respective radiation facilities are indicated in the fol- lowing table with the number of the respective norm requirement.

Aspects

Type of irradiator

Aspects Type of irradiator



Electron beam

Radia-

generator or X-ray

tion

generator

  • The description of packaged product including dimensions, density, orientation within the packaging (see Sections 7 and 9.3.2) as well as the acceptable variations?

  • 9.4.3 a)

  • 9.4.4 a)

 
  • The loading pattern of the product within the irradiation con- tainer (see 9.3.1)?

  • 9.4.3 b)

  • 9.4.4 b)

 
  • The conveyor path(s) to be used for the product (see 9.3.6)?

  • 9.4.3 c)

  • 9.4.4 c)

 

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  • The maximum acceptable dose (see 8.1)?

  • 9.4.3 d)

  • 9.4.4 d)

 
  • The sterilization dose (see 8.2)?

  • 9.4.3 e)

  • 9.4.4 e)

 
  • For products that support microbial growth: the maximum time interval between manufacture and the completion of irradia- tion?

  • 9.4.3 f)

  • 9.4.4 f)

 
  • The routine dosimeter position for dose monitoring?

  • 9.4.3 g)

  • 9.4.4 g)

 
  • The relationships between the dose at the monitoring posi- tions and the minimum and maximum doses (see 9.3.1)?

  • 9.4.3 h)

  • 9.4.4 h)

 
  • Operating conditions of the irradiator and its limiting values (Beam characteristics, conveyor speed)?

n. a.

  • 9.4.4 i)

 
  • For products that are to be exposed to the radiation field more than once, all required re-orientation between exposures?

  • 9.4.3 i)

  • 9.4.4 j)

 
  • 10 Routine monitoring and control

10.1

Are procedures specified for handling of the product and maintenance of product integrity before, during and after irradiation?

 

10.2

Is the number of products during acceptance, loading and unloading, handling and release controlled and are all discrepancies in the count resolved prior to release?

 

10.3

Are all irradiated and non-irradiated products segregated?

 

10.4

Has it been determined, that radiation sensitive visual indicators are not being used as the sole proof of adequate radiation processing or as the sole means of differentiating irradi- ated products from non-irradiated products?

 

10.5

Is the product loaded into the irradiation container in accordance with the process specifi- cation (see 9.4.3, 9.4.4)?

 

10.6-

Are dosimeters used at the predetermined routine monitoring position(s) in sufficient fre-

 

10.7

quency to verify that the process is in control? Are the measured dosimetric results re- corded (see 4.1.2) and analyzed?

10.8

a)

For -irradiators: are the settings of the timer and/or conveyor speed set according to a documented procedure to take account of nuclide decay?

 

10.8

b)

For -irradiators: Is the position of the -source, the setting of the timer and/or conveyor speed and the movement of the irradiation container monitored and recorded (see 4.1.2)?

 

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10.9

For electron beam generators and X-ray irradiators — Are the characteristics of the elec- tron rays (see 9.1.5, 9.1.6) and the conveyor speed monitored and recorded (see 4.1.2)?

 

10.10

Are all process interruptions and non-conformances as well as all corrective actions taken against these monitored and recorded (see 4.1.2)?

 

10.11

Do the records of radiation processing show the date of irradiation and allow the traceabil- ity of batches (see 4.3.2)?

 

11

Product release from sterilization

11.1

Before product release, are all specific periodic tests, calibrations, maintenance work and necessary re-qualifications performed and their results recorded (see 4.1.2)?

 

11.2

Are procedures for the review of records and product release from sterilization specified? Do these procedures define the requirements (see 9.4.3/9.4.4) for designating a steriliza- tion process as one conforming to the standard, taking the uncertainties of the measure- ment system(s) into account?

 
 

If these requirements are not satisfied, is the product considered defective and handled accordingly (see 4.4)?

 

12

Maintaining process effectiveness

  • 12.1 Demonstration of continued effectiveness

12.1.1

Is the continued effectiveness of the established sterilization dose demonstrated by de- termination of the bioburden and inspecting the sterilization?

 
 

Is the frequency of determining bioburden maintained as follows?

 
 

Condition

Frequency of determina- tion of bioburden

12.1.2.1

  • Average bioburden 1,5

At least every 3 months

12.1.2.2

  • Average bioburden 1,5

At least every 3 months

  • Sterilization dose specified at 25 kGy or “Method 2” (15 or 25 kGy, ISO 11137-2) selected (see 8.2.2)

12.1.2.3

  • Average bioburden 1,5

At least every 30 days

  • Sterilization dose specified at 25 kGy or “Method 1” (according to radia- tion resistance, 15 or 25 kGy, ISO 11137-2) selected (see 8.2.2)

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12.1.2.4

  • Time interval between manufacturing of batches is greater than 1 resp.

With

every

manufactured

 

3 months (see conditions mentioned above)

batch

12.1.2.5

In case the result of the determination of bioburden exceeds the specified limit

 
  • Is an inspection according to ISO 11737-1 conducted?

   
  • Are QM-actions taken and an inspection of the sterilization dose conducted, in case the bioburden is evidenced in this inspection?

 
  • Depending on the result of this inspection, are the following procedures implemented?

 

Result

Procedure

 
  • a) Sterilization

dose

Implementation of measures according to 12.1.3.5

 

inspection

unsuc-

 

cessful

  • b) Sterilization dose

Continuing sterilization with the dose used prior to the sterilization dose inspection,

inspection suc-

keeping with the following auxiliary conditions:

cessful,

the

   

bioburden how-

 

In case of

Auxiliary Conditions

 

ever still exceeds

 

the specified limit- ing value

1)

The sterilization dose is established using “Method 1” (ISO 11137-2)

Inspection of sterilization dose every 3 months until bioburden lies within the limiting values or a new steriliza- tion dose is specified

2)

The sterilization dose is established using “Method 2” (ISO 11137-2)

Inspection of sterilization dose every 3 months until compliance with 12.1.3.2 is achieved

3)

A sterilization dose of 25 kGy was se- lected and substantiated using method VD max 25 , average bioburden <1000

Continuation of sterilization dose inspection with current frequency

4)

A sterilization dose of 25 kGy was se- lected and substantiated using method VD max 25 , average bioburden >1000

Acquiring the sterilization dose by means of another procedure

5)

A sterilization dose of 15 kGy was se- lected and substantiated using method VD max 15 , average bioburden <1.5

Continuation of sterilization dose inspection with current frequency

6)

A sterilization dose of 15 kGy was se- lected and substantiated using method VD max 15 , average bioburden <1.5

Acquiring the sterilization dose by means of another procedure

This document becomes invalid when printed or filed in any place other than the original storage location.

Each user must ensure to work only with the currently valid revision of this document!

410.06 Checklist for auditing sterilization

This document becomes invalid when printed or filed in any place other than the original storage

with radiation according to DIN EN ISO 111371:2006 Device:

Ref:

Date:

No.

Question

Evalu-

ation

12.1.3.1

Is one of the following procedures followed in order to establish the frequency of steriliza- tion dose inspections?

 
  • a) A time interval of 3 months between inspections is selected, or

  • b) An explanatory statement for the selection of the time interval is prepared and docu- mented, taking into account and making reports of: review and conclusions reached, with respect to, at least:

1)

Specified limiting value for bioburden

 

2)

Available data from determination of bioburden, the time period during which this data was obtained and the characterization of the microorganisms that comprise the bioburden

 

3)

Available data on the resistance of microorganisms comprising the bioburden

 

4)

The method used to establish the sterilization dose and the cautionary measures related to the procedure

 

5)

The difference between the dose used in routine processing and the sterilization dose, together with a cautionary measure related to this difference

 

6)

The materials of which the product is comprised, especially the usage of materials of natural origin and the control of microbiological quality of these materials

 

7)

Manufacturing process, especially steps in manufacturing that affect bioburden or its resistance

 

8)

Control and monitoring procedures for the manufacturing process

 

9)

Time interval between the manufacturing of different product batches

 

10) The manufacturing environment, especially the extent of microbiological control and monitoring and available data regarding the stability of the environment of the manufacturing over time

 

11) Control of health, cleanliness and clothing of manufacturing personnel

 

12) Available data regarding the microbiological characteristics of other products in the same product family

 

12.1.3.2

On increasing the time interval between inspections of the sterilization dose, are the fol- lowing conditions fulfilled?

 

This document becomes invalid when printed or filed in any place other than the original storage location.

Each user must ensure to work only with the currently valid revision of this document!

410.06 Checklist for auditing sterilization

This document becomes invalid when printed or filed in any place other than the original storage

with radiation according to DIN EN ISO 111371:2006 Device:

Ref:

Date:

No.

Question

Evalu-

ation

 
  • a) There are at least four consecutive inspections of the sterilization dose conducted in the previously selected time intervals, whose results have required neither increase nor reestablishment of the sterilization dose

 
  • b) There is data available to prove the stability of bioburden within its specification over the same time period as above in a). This data includes:

 

1)

Determination of bioburden at least every three months

2)

The characterization of bioburden (e.g. the inspection of colonial or cellular mor- phology, the staining characterizations or the usage of selective culturing)

  • c) The manufacturing of the product is controlled with respect to bioburden and the effec- tiveness of this control is demonstrated by implementing the elements of a QM system for sterile medical products specified in ISO 13485.

 
 

Is an inspection of the sterilization dose conducted

 

12.1.3.4

  • With every manufactured batch, if the time interval between the manufacturing of the charges is greater than the specified time interval between sterilization dose inspec- tions, or

 

12.1.3.3

  • At least every 12 months?

12.1.3.5

If the sterilization dose inspection is unsuccessful, are measures in accordance with ISO 11137-2:2006, Section 10 implemented? Is a sterilization dose inspection conducted every 3 months, until one of the following conditions is fulfilled?

 
  • a) The cause of failure of the sterilization dose audit or the increase in bioburden is in- vestigated and corrections and/or corrective actions are implemented.

  • b) The rationale for the time interval (12.1.3.1) is investigated, and, if necessary, a new time interval is determined.

  • c) The criteria for increasing the time interval according to 12.1.3.2 are fulfilled.

  • 12.2 Recalibration

12.2

Are the accuracy and reliability of all instruments used to control, indicate or record the sterilization process verified periodically (see 4.3.3)?

 
  • 12.3 Maintenance of equipment

12.3.1-

Is there a documented procedure for planning and performing preventive maintenance?

 

12.3.2

Are records regarding this retained (see 4.1.2)? Is a documented inspection for the main- tenance plan / measures / records periodically conducted by a designated person and its result evaluated?

Evalu-

ation

This document becomes invalid when printed or filed in any place other than the original storage location.

Each user must ensure to work only with the currently valid revision of this document!

410.06 Checklist for auditing sterilization

Evalu- ation This document becomes invalid when printed or filed in any place other than the

with radiation according to DIN EN ISO 111371:2006 Device:

Ref:

Date:

Evalu- ation This document becomes invalid when printed or filed in any place other than the

No.

Question

12.4

Requalification of equipment

12.4.1

Is a documented requalification of the sterilization process conducted within a rationalized extent and according to an specified procedure for specified products / equipment:

  • At defined time intervals?

 
  • After assessment of any change (12.5)?

 

12.4.2-

Are requalification procedures specified and records of requalification retained (see

 

12.4.3

4.1.2)? Is requalification data reviewed against specified acceptance criteria in accor- dance with documented procedures and the records of the reviews (see 4.1.2) retained, together with any corrections made and/or corrective actions taken (such as when the specified acceptance criteria are not met)?

12.5

Assessment of change

(to the irradiator / of product / product release from sterilization)

12.5.1

For any change to the radiation facility that could impact the dose or dose distribution, is an assessment carried out? Is there a revalidation (IQ, OQ and/or PQ, see 9.1-9.3) in case of such impacts? Is the outcome of the assessment recorded, including the rationale for the decisions reached (see 4.1.2)?

 

12.5.2

For any change to a product, its packaging or the presentation of a product for steriliza- tion, is there a documented (see 4.1.2) assessment of its effects on the appropriateness of the sterilization process? Are those parts of process definition or PQ that have to be un- dertaken determined based on the nature of the change? Is the outcome of the assess- ment, including the rationale for the decisions reached, recorded?