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Source text - English SYNERGY Health
Titre du document: Procedure VAL/DAT/ON DU PROCEDE Reference: PR014 Revision: IP Date de revision : .iuillet 2015 Page 1 / 14
SYNERGY HEALTH (France)
PROCEURE PRO 4 :
VALIDATION DU PROCEDE
OBJET:
Description des regles a appliquer pour valider !'installation et les procedes du point de vue dosimetrique.
Revision P-Juillet 2015
Redige par
Sandra LE GONIDEC Responsable Qua.lite Production
COPIE NON CONTROLEE
Verifie par
Approuve
Celine SIMONIN Responsable Qualite
THIERRY CAVA
Directeur Executif
MISES A JOUR
Details des principales modifications dans la derniere mise a jour
Justification de la modification
Prise en compte de l' audit interne n° 55 & action CQMS n° 2376
Date d'application : Aout 2015 COPIE NON
CONTROLEE
SOMMAIRE
COPIE
NON
CONTROLEE
1 OBJET ET CHAMP D' APPLICATION 5
2 TE OLOGIE 5
3 QUALIFICATION DE L'I RRADIATEUR (QI et Q0) 6
3.1 Conception et mise en reuvre 6
3.2 Documentation 6
3.3 Qualification Operationnelle 7
3.4 Requalification de l'irradiateur 8
4 QUALIFICATION DES PERFORMANCES (QP) 12
4.1 Prescription des doses 12
4.2 Caracteristiques de la charge 12
4.3 Qualification des performances 12
4.4 Specification du procede 1. 3
4.5 Requalification des pel'formances 13
4.6 Surveillance de la dose 14
1 OBJET ET CHAMP D'APPLICATION
Cette procedure decrit les methodes de validation du procede du point de vue de la dosimetrie (et done des temps de traitement) afin de s'assurer qu'en routine la fourchette de doses prescrite sera respectee par Synergy Health France.
Referentiel : Ce document se veut en conforrnite avec les exigences de la Norme internationale en vigueur ISO 11137-1 intitulee "STERILISATION DES PRODUITS DE SANTE - IRRADIATION - Pa1tie 1: EXIGENCES RELATIVES A LA MISE AU POINT, A LA VALIDATION ET AU CONTROLE DE ROUTINE D'UN PROCEDE DE STERILISATION POUR LES DISPOSITIFS MEDICAUX".
RMQJ : La validation microbiologique, (a !'aide d'indicateurs biologiques par exemple), n'est pas de la responsabilite de Synergy Health en France.
RMQ2 : Cette procedure ne s'applique pas a l 'i rradiateur experimental de Marcoule.
COPIE
2 TERMINOLOGIE
NON
CONTROLEE
Dose absorbee : c'est le quotient deldm, ou de est l'energie moyenne transferee par le rayonnement ionisant a la matiere de masse dm, Elle est aussi appelee dose. Le nom de l'unite
de dose est le gray (Gy): 1 Gy = 1 J.kg-1.
Dose nominale : Dose convenue par commodite administrative pour qualifier la specification ne conespondant pas necessairement aun minimum ou un maximum.
Systeme dosimetrique : systeme utilise pour determiner la dose absorbee, constitue de dosimetres, d'un spectrophotometre, d'un comparateur d'epaisseurs, de courbes d'etalonnage et de procedures pour !'utilisation du systeme.
Absorbance unitaire : quotient de l'absorbance mesuree A a une longueur d'onde donnee par l'epaisseur e du dosimetre. A0 = A I e.
Caitographie dosimetrique: etude de la distribution et de la variabilite de la dose en pla9ant des dosimetres en divers endroits de la charge d'inadiation.
Charge d'irradiation : ensemble de colis introduits dans un compaitiment de nacelle (Marseille)
/ plateau (Marcoule) et traites a la meme dose nominale.
Temps elementaire : temps (en secondes) de stationnement d'une nacelle a l'une des huit positions d'aiTet autour de la source en position haute(Marseille), ou d'un plateau a l'une des 16
positions (Marcoule). Ce temps est controle pai· le chronometre ma1tre de l'installation.
Nombre de tours : nombre de fois qu'une nacelle occupe successivement les huit positions de stationnement autour de la source, ou qu' un plateau occupe successivement les 16 positions.
Fantome : produit conditionne de fa9on a s imuler la densite globale et les cai·acteristiques d'attenuation d'un produit reel.
Categorie de traitement : groupe de differents produits qui peuvent etre sterilises ensemble.
Qualification de !'installation (QI) : processus d'obtention de preuves documentees selon lesquelles les equipements ont ete fournis et installes confonnement a leurs specifications.
Qualification operationnelle (QO) : processus d' obtention de preuves documentees selon
lesquelles l'equipement installe fonctionne dans les limites predeterminees, dans la mesure ou il est utilise conformement a son mode operatoire.
Qualification de la perfonnance (QP) : processus d'obtention de preuves documentees selon lesquelles l' equipement installe et utilise conformement a son mode operatoire fonctionne de...
Pour une triple validation, le plan est revu a la suite des resultats du premier run afm de concentrer les dosimetres dans les zones de dose minimale et maximale (voir MOP N°38).
La norme ISO 11137-1 preconise d'effectuer des cartographies distinctes pour chaque categorie de traitement, ou pour chaque assemblage du meme produit. Ainsi pour des charges variables, deux exercices de caitographies sont necessaires : l'une sur la charge minimale (volume et/ou densite minimale) et l'autre sur la chai·ge maximale (volume et/ou densite maximale).
Des fai1tomes peuvent etre utilises aux emplacements ou les doses sont hors limites ou pour reproduire en routine !'assemblage etudie au cours de la caitographie dosimetrique..
Toutes les donnees, y compris les parametres d'inadiation, les resultats et les conclusions tires de Ia caitographie des doses (definition des categories de traitement, determination des temps
d'exposition necessaires, de !'emplacement des doses extremes, des endroits oit !es dosimetres devront etre places en routine, s'ii y a lieu des coefficients a appliquer en cas de mesure indirecte ... ) sont consignees dans un rapport.
Ce rapp01t de cartographie est redige sur la base du modele CRCARTOF (en frarn;ais) ou du modele CRCARTOA (en anglais).
L'analyse des donnees issue des validations multiples est effectuee selon une methode statistique (telle que AAMI TIR29 ou ASTM 2303- voir MOP n°38). Si pour un exercice, la dose minimale, maximale ou du dosimetre de routine obtenue est significativement differente des doses obtenues lors des deux autres exercices (c'est-}1-dire plus de 8% pour Mai·seille et
10% pour Mai·coule) alors cet exercice doit etre exclude !'analyse et une caitographie supplementaire doit etre repetee dans les plus brefs delais.
Le rapport est signe par deux personnes. Une personne habilitee qui le redige et une personne du Service Qualite qui verifie au minimum conclusion et pai·ametres de traitement defini.
Lorsque le traitement effectue en routine necessite de disposer les colis selon un plan de charge particulier ou de placer des dosimetres autres que ceux poses habituellement, un plai1 est a la disposition du personnel a la reception ainsi qu'au paste de chai·gement des nacelles pour le site de Maiseille. La fiche a reception en fait mention.
Note: Les surdosages pouvant avoir lieu !ors des validations ne seront pas consideres comme
des non-coriformites.
4.4 Specification du procede
COPIE
NON
CONTROLEE
LA FOURCHETTE DE DOSES EXIGEE PAR LE CLIENT SUFFIT A SPECIFIER LE
PROCEDE. Cette specification fait l'objet d'un ecrit.
4.5 Requalification des performances
Toute modification a !'initiative du client pouvant avoir une incidence sur la repaitition de la dose (changement de conditionnement, changement important des caracteristiques des
produits...) doit dormer lieu a une requalification, dont!'initiative revient egalementau client.
Titre du document : Procedure VALIDATlON DU PROCEDE
Reference : PR0 14 Revision : I P
Date de revision : juillet 2015 Page 14 / 14
La modification de la source ne necessite pas !'elaboration d'une nouvelle specification du procede mais doit faire l'objet d'une requalification si elle resulte en une modification de la distribution des doses.
I Par defaut, la validite des cartographies dosimetriques a ete fixee a 5 ans. Une requalification des performances doit done avoir lieu avant cette echeance. COPIE
NON
4.6 Surveillance de la dose CON1"'ROLEE
Les donnees acquises lors des traitements de routine sont examinees, notamment pour toute mesure dosimetrique indiquant qu'une dose se situe hors des limites specifiees (voir PRO 11) :
Le surdosage constitue une non-conformite (sauf s'il survient au cours de la validation du procede) et la procedure PRO 02 s'applique ;
Le sous-dosage est un ecart reparable. Un traitement complementaire peut etre applique au produit.
Dans ces deux cas et meme clans le cas ou les doses sont clans les limites specifiees, une comparaison entre les valeurs des doses pour le temps d'exposition appliquee et la fourchette
de temps de traitement determinee dans la validation peut-etre effectuee de fayon a pouvoir reajuster cette fourchette de temps et eviter ainsi un nouveau surdosage (ou un surdosage potentiel) ou des complements de traitement frequents.
Translation - French SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 1/14
SYNERGY HEALTH (France)
PROCEDURE PRO 14:
PROCESS VALIDATION
SUBJECT: Description of rules to apply for validating the installation and processes from a dosimetric perspective.
Revision P-July 2015
UNCONTROLLED COPY/ ORIGINAL
Written by Sandra LE GONIDEC
Production Quality Manager
Verified by Céline SIMONIN
Quality Manager
Approved by THIERRY CAVA
Executive director
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 2/14
UNCONTROLLED COPY/ORIGINAL
UPDATES
REV. DATE DESCRIPTION OF CHANGES
A 01/07/93 Cancelled and replaced CARTOGRA Revision C of 26/04/91
B 10/18/93 Precision added to the archiving process and the waste book manager
C 12.07.94 Changed the date of edition of the EN 552 standard
Replaced the micrometer by the comparator
D 11/10/96 Changed the person in charge of mapping
E 01/28/97 Consideration of the workbook, "Palletization plan".
F 11.03.98 Amendment of paragraph "requalification of the installation"
G 23.02.99 Amendment of paragraph “requalification of the installation "
H 12/04/02 Amendment of paragraph 4.3 "dose mappings"
J 18/04/03 Amendment of paragraph 3.2 "documentation"
Addition of section 4.6 "Monitoring of the dose"
K 26/11/04 Integrated triple validations
L Sept.-05 Details of cases requiring a requalification of the installation.
Modification of: tests performed after the modification, the acceptance criteria, the organization and responsibilities.
M Dec.-06 Consideration of the ISO 11137-1: 2006 standard
Terminology: definition of category of treatment, IQ, OQ and PQ
Precisions brought to the content of dosimetric reports
QP & requalification: Precision brought to the validation of variable loads.
Details on the conclusions to be drawn as a result of the mapping.
Dosimetric mapping is valid for 5 years.
N July-13 Integrated Marcoule and removed the EN 552 standard
Taking account of the new ERP (IFS) and precision on IQ
Use according to a statistical method (AAMI TIR29 or ASTM 2303) for analysis of data, outcome of multiple validations
Precision on who can sign the QP reports
P June-15 See below
Details of the main changes in the last update
Section:
2 Terminology: definition of the irradiation load for Marcoule
3.1 Design and implementation: Replacing the Technical Director (Marseille) with the Executive Director
3.2.1 Documentation relating to the installation: Replacing the Technical Director (Marseille) with the Executive Director
3.3 OQ: addition of the date of the initial mapping of the Marcoule site & coding dosimeters as per the initial OQ of the Marcoule site
3.4.1 Step to be performed before the change: customers are informed by the Quality Department by email rather than by fax
3.4.2.3 Addition of the dosimetric uncertainty of Marcoule
4.3 PQ: Inclusion of validation assistants for the realization of maps & the acceptance criterion for Marcoule.
4.5 Performance requalifiquation: precision added to the validity of dosimetric mapping
Change that does not require any training.
NB: the "I" symbol which appears in the margin indicates that a change has been made in this paragraph.
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 3/14
Justification for Change
Consideration by the internal audit No. 55 & action CQMS No. 2376
Date of implementation: August 2015
UNCONTROLLED COPY/ORIGINAL
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 4/14
UNCONTROLLED COPY
SUMMARY
1 PURPOSE AND SCOPE…………………………………………………………… ………...5
2 TERMINOLOGY…………………………………………………………….……… ……….5
3 QUALIFICATION OF IRRADIATOR (IQ and 0Q)……………………………… ….……6
3.1 Design and implementation………………………………………………….…. ……6
3.2 Documentation………………………………………………………………..….……6
3.3 Operational Qualification……………………………………………………… ….....7
3.4 Requalification of the irradiator…………………………………………… …… ..…8
4 Performance Qualification (PQ)…………………………………………………………..…12
4.1 Specification of doses………………………………………………………………..12
4.2 Characteristics of the load……………………………………………………………12
4.3 Performance Rating…………………………………………………………………..12
4.4 Specification of Process………………………………………………………………13
4.5 Requalification of performances………………………………………………… …..13
4.6 Monitoring the dose……………………………………………………………… ….14
ORIGINAL
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 5/14
1 PURPOSE AND SCOPE
This procedure describes the process validation methods from the standpoint of dosimetry (and gives the processing time) to ensure that the prescribed routine dose range will be respected by Synergy Health France.
Repository: This document is in compliance with the requirements of the international standard ISO 11137-1 in force entitled "STERILIZATION OF HEALTH CARE PRODUCTS -- RADIATION -- PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES".
RMQJ: Microbiological validation (with the help of biological indicators, for example) is not the responsibility of Synergy Health in France.
RMQ2: This procedure does not apply to the experimental irradiator of Marcoule.
UNCONTROLLED COPY
2 TERMINOLOGY
Absorbed dose: it is the quotient dE/dm, where dE is the mean energy transferred by ionizing radiation to matter of mass dm. It is also called dose. The name of the unit of the dose is gray (Gy): 1 Gy = 1 J kg–1.
Nominal Dose: Dose agreed through administrative convenience to describe the specification not necessarily corresponding to a minimum or maximum.
Dosimetry system: system used to determine the absorbed dose, comprised of dosimeters, a spectrophotometer, a thickness gauge, calibration curves and procedures for use of the system.
Absorbance unit: quotient of the measured absorbance at a wavelength given by the thickness of the dosimeter. A0 = A/e.
Dosimetric mapping: study of the distribution and variability of the dose by placing dosimeters across various paths of the irradiation load.
Irradiation load: a set of packages introduced into a nacelle compartment (Marseille)/ tray (Marcoule) and subjected to the same nominal dose.
Elementary time: time (in seconds) for stopping a nacelle at one of the eight stop positions around the source found at a high position (Marseille), or a tray to one of the 16 positions (Marcoule). This time is controlled by the stopwatch overseeing the installation.
Number of runs: number of times a nacelle consecutively holds the eight stop positions around the source, or that a tray consecutively holds the 16 positions.
Phantom: product customized in such a way as to mimic the overall density and attenuation characteristics of a real product.
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 6/14
Processing category: group of different products that can be sterilized together.
Qualification of installation (IQ): process for obtaining documentary evidence which record how equipment were provided and installed as per their specifications.
Operational qualification (OQ): process for obtaining documentary evidence, according to which equipment installed operates within predetermined limits and that it is used in accordance with its operating mode.
Performance qualification (PQ): process for obtaining documentary evidence, according to which equipment installed and used in accordance with its operating mode work in a consistent manner, in accordance with predetermined criteria, and that it therefore delivers a product in compliance with its specifications.
UNCONTROLLED COPY/ORIGINAL
3 QUALIFICATION OF IRRADIATOR (IQ and OQ)
3.1 Design and implementation
The parameters of use (see document "Operational Qualification of the Installation")
are controlled and audited periodically by the operators under the responsibility of the Executive Director (Marseille) / Facility Director (Marcoule) and the registration of verifications are kept under their care (cf. PRO 07 "management of registration").
During the processing, the system provides continuous information on the correct positioning of the source. Any anomaly regarding the conveyor or the stopwatch results in the lowering of the source, the stop the conveyor and therefore the interruption of the processing. All source movements are recorded in an electronic events log by operators used to intervene in the control room. Interruptions in processing are registered.
In Marseille, there are two zones separated physically, differentiating processed products from unprocessed products.
In Marcoule, this distinction is made only for the Reception & Redirection part. The storage of goods is then done via the operating gantry crane, fully automated and validated for this purpose (IT segregation).
3.2 Documentation
3.2.1 Documentation relating to installation
The installation plans, the specifications and characteristics, the operational modalities of the system, the conveyor maintenance methods, and information relating to the source are consigned to written documents held by the Executive Director (Marseille) / Facility Director (Marcoule) and preserved at the technical office (Marseille) / office of the Facility Director (Marcoule).
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 7/14
A description of the process of installation is also available.
The description of equipment which has been the subject of an IQ is included in the following documents:
- The General Operating Rules
- The Safety Report
3.2.2 Documentation relating to control of operation
Equipment used for controlling, monitoring and registering lengths of exposure is logged (see PRO 04).
3.2.3 Documentation relating to processing
UNCONTROLLED COPY
All data relating to each Synergy Health processing batch are electronically recorded.
A batch file (paper) is also compiled on-site (see MOP 10).
Information relating to the traceability of nacelle/tray processing, identified individually by its number, is available; the same applies for comprehensive information on the dosimetry of the relevant batch (dosimeters read, doses received, processing time, etc. ...).
3.2.3.3 Waste book
All source movements (date, time, reason, classification of intervention) are recorded in a computerized waste book.
3.3 Operational Qualification
Marseille site:
Initial mapping of doses were performed at startup of the facility in April 1989 with materials of a homogeneous density (sawdust, flour ...). They were used to determine the absorbed dose using Perspex dosimeters placed at different depths of pallets occupying the entire volume of the nacelles.
The irradiator was of "source overflowing" type. The efficiency of the cobalt of such type of irradiator could be improved by converting a kind of "overflowing product." This change
was initiated in May 2004 and it was followed by new dose mappings (see document "Operational Qualification of installation ").
Marcoule site:
The initial mappings of doses were performed at startup of installation in January
and in August 2014, with materials of homogeneous density (polystyrene, cardboard ...). They helped determine absorbed doses using Perspex dosimeters at different depths of pallets occupying all the available volume. A protocol of Operational Qualification was realized for this purpose (Doc. OQ protocol Validation Marcoule).
The coding used for the positioning of dosimeters in Marseille is subject to the operating mode MOP 15. The coding used for the positioning of dosimeters in Marcoule results from the initial protocol of the first Operational Qualification of the installation.
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 8/14
UNCONTROLLED COPY/ORIGINAL
3.4 Requalification of the irradiator
Requalification of the irradiator should be effected as a result of one of the events listed below:
a) After adding, removing or rearranging sources.
b) After a modification of the irradiation container (nacelle/ tray).
c) After a modification of the inside of the irradiation cell of the conveyor.
d) After a modification to the product circuit.
e) After a change in the geometry of the frame of the source-holder.
f) After a change that affects the source-product distance.
g) After an event that alters dose distribution or heterogeneity.
h) After a change in the position of the frame of the source-holder.
Changes b) to h) require a partial or total requalification of the irradiator.
The modification a) corresponds to an irradiator change that can affect the distribution of absorbed doses by products. Only the realization of maps is required after each of these changes (OQ). These maps are designed to detect eventual changes in dose distribution and to calculate the correcting factor
resulting from the change in activity. A new requalification process would not be effected if the study concludes that the change has had an influence on the distribution of doses.
3.4.1 Actions to be taken before the modification
Approximately one month before the proposed date of the modification, the Quality Department is responsible for informing clients, for whom contracts for processing via gamma radiation exist, in which this requirement is specified, via email. These can then judge whether it is necessary to realize a mapping on their products immediately after recharging, or if they can wait for the conclusions of the requalification.
3.4.2 Actions to be taken after the change
3.4.2.1 Processing via pallets
Mapping is made on several pallets of fake products or those actually entrusted by the clients. The used fillers are chosen because of their reproducibility, and mappings must be performed on comprehensive pallets of products with homogeneous density.
At least two mappings of irradiator doses are performed: one with a product whose density is close to the lower limit of the range of the density of medical products for which the irradiator is used and another with a product whose the density is close to the upper limit of this range.
The method used is as follows:
1. A triple validation is performed on each selected density in order to determine the variability in the dose and the dose distribution between the pallets.
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 9/14
2. The number of dosimeters placed on each pallet must not be less than 60. They are distributed within the load as per a three-dimensional model in such a way as to determine the positions of the minimum and maximum doses as well as the dose distribution. Depending on the results of the first run, the number of dosimeters for the other two runs may be reduced so that they can be placed in the minimum and maximum dose areas.
3. The average dose values read for each dosimeter over the three exercises is calculated and recorded.
4. These averages are used to confirm:
The relationship between time of exposure and the dose absorbed at each position of the pallet for the relevant density;
The heterogeneity of doses (ratio between the maximum dose and dose Dmax and the minimum dose Dmin).
The relationship between the minimum dose and the dose in the FAZ position (Marseille) and GAO (Marcoule) (most used point of reference for indirect reading of the routine dose).
The relationship between the maximum dose and the dose in the FAZ position (Marseille) and GAO (Marcoule)
The positions of the minimum dose and maximum dose.
Shelves (if applicable): a mapping a study is carried out on each shelf used for
small volumes (carton processing). Two types of loads are mapped: one with a minimum density and minimum volume and one with a maximum volume and density.
The number of dosimeters placed on each shelf must not be less than 20.
Incomplete pallets: a mapping is also performed on an incomplete pallet whose height is equal to three-quarter to half or a quarter of the height of a complete pallet (by alternating at each change).
The number of dosimeters must not be less than 20.
3.4.2.3 Analysis of results and acceptance criteria of the change
Reproducibility of treatment:
The results of triple validations are brought to an average processing time, and average values of doses read at every position are calculated and sorted by increasing doses. This data is used to calculate the time required to reach a minimal dose as well as the values of the heterogeneity of the processing.
Criteria for acceptance of the change:
• The positions of the minimum and maximum doses of each pallet must be identical (within the limits of Dosimetric uncertainty of 6% (Marseille) / 7% (Marcoule)),
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 10/14
• The value of the gap between the processing time (for a given minimum dose) calculated for each run should be between +/- 6% (Marseille) / +/- 7% (Marcoule) calculated over the average time on 3 runs,
•
• The value of the gap between the Dmax / Dmin relationship calculated for each run should be between +/- 6% (Marseille) / +/- 7% (Marcoule) of the Dmax / Dmin relationship average calculated over the outcome of 3 runs,
Note: any position for which the value of the dose between the extreme dose
+/- 6% (Marseille) / + / - 7% (Marcoule) (value of the uncertainty) should be considered as a
potential extreme position.
UNCONTROLLED COPY/ORIGINAL
Density = Before After Difference
Batch#
Activity (Ci) Tps Before Tps After
Time
(X) Dose Position Dose Position
Min dose Dml
Dm2 Pml
Pm2 Dml '
Dm2' Pml'
Pm2'
Max dose DM1 DM2 PM1 PM2 DMI' DM2' PM1' PM2'
Reference for dose position (kGy)
Dref FAZ / GAO
(Pallet) or IAOx (shelves) Dref'
FAZ GAO
(Pallet) or IAOx (shelves)
Min coefficient Cm = Dm1/Dref Cm '= Dml'/Dref' Ecm = ((Cm' - Cm) / Cm) x 100
Max coefficient CM = DM1/Dref CM' = Dml 'I Dref' EcM = ((CM' - CM) / CM) x 100
Time (X) for y k Gy min Rt = Tps Before/ Dml * y
Rt '= Tps After / Dml' * y
E = ((Rt' - Rt) / Rt) X 100
Dmax/Dmin Rd = DMI / Dml Rd' = DMI' / Dml' Erd = ((Rd' - Rd) / Rd) x 100
Comparing the measurements before and after the change:
Each mapping study is the subject of a report presenting the results of the dosimetric study and a comparison with the results obtained as a result of mapping made before the modification on the same loads.
These results are presented in a table, with an example below:
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Document title: Procedure PROCESS VALIDATION
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UNCONTROLLED COPY
Criteria for acceptance of the change:
• The position of the minimum and maximum doses must remain unchanged
(within the dosimetric limits of uncertainty 6% (Marseille) / + / - 7% (Marcoule)).
• The values of differences between extreme doses and doses at the reference point (Ecm and EcM) must be between +/- 6% (Marseilles I +/- 7% (Marcoule)
• The value of the difference between the processing time (E) must be between +/- 6
% (Marseille) / + / - 7% (Marcoule).
• The value of the difference in the heterogeneity (Erd) must be between +/- 6 ¾ (Marseille)
I +/- 7% (Marcoule).
3.4.2.4 Organization and conclusion of requalification
The authorization for processing is given by the Executive Director / Facility Manager and the Quality Manager in two steps:
1. A first authorization is given by the Executive Director / Facility Manager and the Quality Manager after calculating the new value of X (MOP 35). At the very least, a triple validation will be programed with the restart of the installation for one of the two densities selected as well as a simple mapping for the second density. Other products that can be processed must either have a wide range of doses prescribed, or not be a product for medico-surgical use.
2. After processing, summary tables analyzing the results (at the minimum of the triple validation for the first density and the simple validation for the second density), are transmitted to the Quality Manager. The latter verifies that the acceptance criteria have been met and if that is the case, he allows the continuation of processing.
If the differences are outside the range or if there has been a significant change in the position of the minimum dose or the highest dose, then the position of the sources should be adjusted and the exercise should be repeated until the limits are met. If this cannot be realized, then all the dose mappings of the products will have to be redone.
The mapping of the dose of irradiation is supplemented as soon as possible with the remaining studies. Each is reviewed by the Quality Manager by taking into consideration the criteria of acceptance.
A report containing all the data relating to the modification is then drafted.
In order to conclude that the change will have no influence on routine processing, the criteria of acceptance must have been fulfilled. If this is not the case, clients who performed mapping would be informed before conducting a processing of their products anew. All dose mappings of products must therefore be redone.
The final authorization to pursue processing or not is given by the Executive Director based on the findings of the report.
A summary of the report is sent to clients who request it.
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 12/14
UNCONTROLLED COPY
4 PERFORMANCE QUALIFICATION (PQ)
4.1 Prescription of doses
Before undertaking the performance qualification, it is for the client to determine, as per his own criteria:
the minimum dose to be delivered anywhere in the product, the latter being generally linked to an
efficiency threshold (for example, the dose required to achieve a degree of insurance sterility equals to 1o-6) the maximum dose. This is usually linked to a tolerance threshold (e.g. degradation of features of a material).
4.2 Characteristics of the load
The dimensions and weight of each package and its assembly, and, in due course, the particular positioning in the nacelle, are recorded. A three-dimensional plan of the load is included in the mapping report.
4.3 Performance Qualification
Performance Qualification (or dose mapping) is performed, by the Head of Dosimetric Validation / Validation Assistant or any other person so authorized, by distributing the dosimeters in the relevant load. The number of assemblies to be mapped (and possibly the number of dosimeters to be used) is determined in agreement with the customer, especially depending on the batch size entrusted.
The number of assemblies tested and the number of dosimeters used should be sufficient to be representative and to take into account the variability of the results.
For this purpose and as regards the sterilization of medical devices, clients concerned are advised to realize three dosimetric mapping exercises.
They must unavoidably let their stance known: either realization of the triple validation (recommended) or realization of one exercise with the application of a safety margin of +/-5% (Marseille) & 6% (Marcoule) based on the calculation of processing time to be routinely applied.
For other types of products only one exercise is carried out with application of the safety margin of +/- 5% of security (Marseille) & 6% (Marcoule).
The plan for the positioning of dosimeters is defined by the one responsible for mapping based on characteristics of the load and the results of dosimetric mappings made during operational qualification of the irradiator and the data of mappings performed on products whose apparent volume and density are similar.
It is recorded in a preparation sheet for dosimetric mapping (Model PREPCART) and is subjected to the approval of a second person, a member of the Quality Department, before the placing of the dosimeters.
Note: there is no approval of this preparation sheet when it is established by the Head of Dosimetric Validation when it comes to revalidating mapping identical to the preceding ones.
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 13/14
For a triple validation, the plan is reviewed after the results of the first run in order to focus the dosimeters in areas of minimum and maximum dose (see MOP No. 38).
The ISO 11137-1 standard advocates that distinct maps are performed for each category of processing, or each assembly of the same product. Therefore, for varying loads, two mapping exercises are needed: one of the minimum load (volume and / or minimum density) and one of the maximum load (volume and / or maximum density).
Phantoms may be used at the locations where the doses are off limits or in order to routinely reproduce the assembly studied during the dosimetric mapping...
All data, including parameters of irradiation, the results and the conclusions drawn from the mapping of doses (definition of categories of processing, determination of time of exposure necessary, location of extreme doses, places where dosimeters should be routinely put in place, and if needed, the coefficient to apply in cases of indirect measurement ...) are recorded in a report.
This mapping report is drafted based on the model CRCARTOF (in French) or CRCARTOA model (in English).
Analysis of data after multiple validations is performed using a statistical method (such as AAMI TIR29 or ASTM 2303- MOP see No. 38). If for an exercise, the minimum dose, maximum dose, or routine dosimeter obtained is significantly different to doses obtained from the two other exercises, that is, more than 8% for Marseille and 10% for Marcoule) then this exercise must exclude the analysis and a supplemental mapping must be repeated within the shortest possible time.
The report is signed by two persons. An authorized person who drafts and a person from the Quality Department who verifies, at the very least, the conclusion and set processing parameters.
When the processing performed routinely requires that the packages be disposed of using a particular load or placing dosimeters other than those usually placed, a plan is available to the staff at the reception as well as the nacelle-changing post at the Marseille site. The sheet at the reception mentions this.
Note: Overdoses which can occur during validations will not be considered as nonconformities.
UNCONTROLLED COPY/ORIGINAL
4.4 Specification Process
THE RANGE OF DOSES REQUIRED BY THE CLIENT IS SUFFICIENT TO SPECIFY THE
PROCESS. This specification is the subject of a writing.
4.5 Performance requalification
Any modification at the client’s initiative that can affect the distribution of the dose (packaging change, significant change in the characteristics of products ...) must be subject of a new requalification, and this new initiative must be requested by the client.
SYNERGY Health
Document title: Procedure PROCESS VALIDATION
Reference: PR014 Revision: P
Revision date: July 2015 Page 14/14
UNCONTROLLED COPY/ ORIGINAL
Changing of the source does not require the drawing up of a new specification of the process, but must be subject to a requalification if it results in a change in dose distribution.
By default, the validity of dosimetric mapping has been fixed at 5 years. Performance requalification must therefore take place before the end of this period.
4.6 Monitoring of the dose
The data acquired during routine processing are discussed, with regard to any dosimetric measurement indicating that a dose is outside the limits specified (see PRO 11):
- Overdosing is a non-compliance issues (unless it occurs during the validation of the process) and the procedure PRO 02 applies;
- Underdosing is reparable gap. A supplementary processing can be applied to the product.
In both cases and even in cases where the doses are within the limits specified, a comparison between the values of doses for the length of applied and the range of time determined in the validation process may be effected in such a way as to be able to readjust this range of time and thus avoid a new overdosing (or a potential overdosing) or frequent supplementary processing.
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