RGV ECP SOP's Flashcards
1
Q
APHIS
A
Animal Plant Health Inspection Services (Division of USDA)
2
Q
CBP
A
Custom and Border Protection
3
Q
LIMS
A
Logistics Information Management System
4
Q
Non-Program Articles
A
Plant products not covered under the irradiation operational work
plan.
5
Q
NPPO
A
National Plant Protection Organization, the official service established by a
government to discharge the functions specified by the International Plant Protection
Convention
6
Q
PPQ
A
Plant Protection & Quarantine (Division of APHIS, Division of USDA)
7
Q
Program Articles
A
Plant products covered under the irradiation operational work plan.
8
Q
RPC
A
Reusable Plastic Containers
9
Q
Standard Operating Procedures (SOPs)
A
Procedures developed and documented by each
facility that address irradiation of commodities for mitigation of plant pests. This document
must be in place before the facilities are offered for certification. It must include the “how to” for all the facets of handling, safe guarding and treating the commodities. Critical control points are dose, dosimetry and safeguards. SOPs will be reviewed along with facility specifications and personnel qualifications in determining the acceptability for certification.
10
Q
USDA
A
United States Department of Agriculture
11
Q
BOL
A
Bills of Lading (BOL) indicating the number of units/boxes included on the
conveyance
12
Q
PPQ Form 519
A
Importer Compliance Agreement
13
Q
CBP Form AI-523A
A
Chain of Custudy
14
Q
CBP Form AI-625
A
Sealing Report and Authorization to Proceed
15
Q
PPQ Form 368
A
Notice of Arrival
16
Q
TIN
A
Treatment Identification Number (assigned to each lot), Name of Irradiation Facility, Treatment Facility Code, and Treatment Date.
17
Q
PPQ Form 523
A
Emergency Action Notification
18
Q
Dosimetrist
A
A trained and properly credentialed staff member responsible for dosimetry at the facility as well as dose mapping. [ISPM No. 18]
Is responsible for supervising the completion or completing Pre-Treatment Dose Mapping Configuration
The Dosimetrist will place dosimeters at the predetermined location for each box configuration (based on approved dose mapping) in the product box for each load of product to ensure that the food items are treated with a minimum absorbed dose as required per USDA regulations
(Reference: Rule 7 CFR Parts 305, Table 3-8-1).
The Dosimetrist will place or supervise the placement of Dosimeters in cases from the first pallet of each shipment induced into the material handling system as well as in cases from the final pallet of each shipment. Cases that contain the dosimeters are marked with a ‘Dosimeter Flag’ for retrieval of the device post treatment. The Dosimetrist must ensure that the
Dosimeters are place in the cases according to the approved dose mapping procedure as documented in Section 11 of this SOP Document
19
Q
Dose Mapping
A
Measurement of the absorbed dose distribution within a process load through the use of dosimeters placed at specific locations within the process load [ISPM No.
18]
20
Q
Dosimeter
A
A device that, when irradiated, exhibits a quantifiable change in some property of the device which can be related to absorbed dose in a given material using appropriate analytical instrumentation and techniques [ISPM No. 18]
21
Q
Lot
A
A shipment of articles sent from a single production area to a packing house in one day and allotted by a unique code number by the packing house facility before it leaves for the treatment facility.
22
Q
Pre-Treatment Inspection
A
Inspection of commodity prior to irradiation treatment.
23
Q
Pre-Treatment Dose Mapping Configuration
A
The process of configuring a shipment for Dose Mapping.
24
Q
Auxiliary Compliant Articles
A
Articles that are not subject to a required phytosanitary
treatment and are destined for irradiation treatment
25
ECP
Electronic Cold-Pasteurization
26
Dmax
The localized maximum absorbed dose within the process load [ISPM No. 24, 2005]
27
Dmin
The localized minimum absorbed dose within the process load [ISPM No. 24, 2005]
28
Dosimetry
A system used for determining absorbed dose, consisting of dosimeters, measurement instruments and their associated reference standards, and procedures for the system's use [ISPM No. 24, 2005]
29
Gray (Gy)
Unit of absorbed dose where 1 Gy is equivalent to the absorption of 1 joule per kilogram (1 Gy = 1 J.kg-1)
30
Irradiation
Treatment with any type of ionizing radiation [ISPM No.24, 2005]
31
Process load
A volume of material with a specified loading configuration and treated as a single entity [ISPM No. 24, 2005]
32
RADURA
internationally recognized symbol used to indicate when a food product has been irradiated
33
TLD
Thermo-Luminescence Dosimeter
34
RSO
Radiation Safety Officer (RSO) is responsible for carry out radiological surveillance and personnel monitoring at the irradiation facility and maintain records of personal exposure to radiation.
Will closely monitor the radiation levels at all delineated areas that may be exposed to radiation above ambient levels. It is mandatory that all control room personnel, will wear TLD badges. Employees will submit the exposed badges at periodic intervals to the Facility Lead Dosimetrist for processing to ensure employee safety.
35
Cycle Time
Is the time taken by the product box to move from its position to next box position. Any time the speed of the conveyor is changed; it is verified by a time out logic that is displayed in terms of supply frequency. The cycle time is set on the basis of minimum dose required to be delivered.
36
CGMP
Current Good Manufacturing Practice, practices that conform to guidelines and regulations of the FDA. Also referred to as “GMPs”. [As sourced from 21 C.F.R. § 110 2016, 21 C.F.R. § 112 2016, 21 C.F.R. § 117 2016, 21 C.F.R. § 121 2016]
37
CTI
Certificate of Treatment by irradiation, generated by IRAD
38
FDA
Food and Drug Administration
39
FSMA
FDA Food Safety Modernization Act [Public Law 111-353]
40
IRAD
Irradiation Reporting and Accountability Database, USDA-APHIS
41
Plant
Building or parts thereof used for or in the connection with the manufacturing, packaging, labeling, or holding of human food. [21 C.F.R. § 110.3(k) 2016]
42
Post-Treatment Storage
The storage of articles after completion of irradiation treatment.
43
Post-Treatment Handling
The handling of articles after completion of irradiation
| treatment.
44
Treatment Label:
A unique label generated and placed on each case at time of treatment at the facility.
45
USDA/APHIS Inspector
is responsible for authorizing the release of treated program articles.
46
NPMA
National Pest Management Association
47
Pest
any objectionable animals or insects including, but not limited to, birds, rodents, flies, and larvae. [21 C.F.R. § 110.3(j) 2016]
48
IGRs
insect growth regulators
49
ILTs
Insect light traps
50
form NPMA 38
shall be used to record observations and
| recommendations and a copy shall be disclosed to and signed by the plant contact.
51
Big Eight
Food allergens include: cow’s milk, eggs, peanuts, tree nuts, soybean products, wheat, fish, and crustacean
shellfish
52
HACCP
Hazard Analysis and Critical Control Points is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level.
53
Adulterated
Articles that fail to federal standards. [21 USC § 342]
54
Controlled Data
information that is a required component of any document, record, or other mechanism that is subject to any required hold, preservation, maintenance,
reproduction, access, or similar instrument.
55
Controlled Document
a document that is formally identified, registered, and maintained; their change and implementation is regulated.
56
Controlled Record
a record that is kept and maintained under safeguard for future reference in an audit and/or for traceability.
57
Data
information contained within documents, records, or systems that can be quantified and interpreted.
58
Document
written, printed, or electronic matter that provides information or evidence or that serves as an official record.
59
Internal Data
information that is not a required component of any document, record, or other mechanism that is subject to any required hold, preservation, maintenance,
reproduction, access, or similar instrument.
60
Internal Document
a document that is generated, maintained, or implemented as a component of facility procedures that either contained proprietary information or is not
controlled and outside the limits of the administrative system.
61
Internal Record
a record that is not required to kept, maintained, reproduced, or utilized in connection with any mandated or requested audit, recall, or other investigation.
62
Master Data List
repository of all internal, external, controlled, and non-controlled data along with data identification, data system of record, data owner, data definitions, data
storage rules, data access rules, and data relationships to documents.
63
Master Document List:
repository of all internal, external, controlled, and non-controlled documents along with document names, document titles, document owner, document version, document revision dates, document approval dates, as well as document revision approval dates.
64
Master Record List
repository of interdependency information between Master Document List and Master Data List.
65
Procedure
document containing information relative to the performance of a given task; to include the responsible parties, methods for performing relevant task, required materials or equipment, precursor activities, dependent activities, activity locations, and fundamental purposes of titular activity/task.
66
Record
document written, printed, stored electronically, product statement, or sample statement which is approved or authorized to confirm that a procedure or component of a procedure has been completed to the approved specifications contained within the
referenced procedure.
67
Treatment Data Office
is responsible for the management, maintenance, security, access, and integrity of controlled treatment documents, records, and data.
68
Absorbed-Dose Mapping
measurement of absorbed dose within an irradiated product to produce a one-, two- or three-dimensional distribution of absorbed dose, thus rendering a map
of absorbed-dose values.
69
Calibration Curve
expression of the relation between indication and corresponding measured quantity value.
70
DUR
Dose Uniformity Ratio: ratio of the maximum to the minimum absorbed dose within the irradiated product
71
Dose Zone
a volume or discrete point(s) within a process load that receives the same absorbed dose within the statistical uncertainty of the irradiation process and absorbed- dose measurement(s).
72
Installation Qualification (IQ)
process of obtaining and documenting evidence that
| equipment has been provided and installed in accordance with its specification.
73
Operational Qualification (OQ)
process of obtaining and documenting evidence that
| installed equipment operates within predetermined limits when used in accordance with its operational procedures.
74
Performance Qualification (PQ)
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.
uses specific product to demonstrate that the facility consistently operates in accordance with predetermined criteria to deliver specified doses, thereby resulting in product that meets the specified requirements. Therefore, the objective of performance qualification is to establish all process parameters that will satisfy absorbed dose requirements. This is accomplished by establishing the dose distribution
throughout the process load for a specific product loading pattern. Key process parameters include electron beam energy, beam current, material handling system parameters (conveyor speed or irradiation time), beam width, process load characteristics and irradiation conditions.
75
Irradiation Container
holder in which process load is transported through the irradiator
76
Processing Category
group of different product that can be processed together
77
Reference Material
homogeneous material of known radiation absorption and scattering properties used to establish characteristics of the irradiation process, such as scan
uniformity, depth-dose distribution, throughput rate, and reproducibility of dose delivery.
78
Routine Monitoring Position
position where absorbed dose is monitored during routine processing to ensure that the product is receiving the absorbed dose specified for the process.
79
Simulated Product:
material with attenuation and scattering properties similar to those of the product, material or substance to be irradiated.
Simulated product is used during irradiator characterization as a substitute for the actual product, material or substance to be irradiated. When used in routine production runs in order to compensate for the absence of product, simulated product is sometimes
referred to as compensating dummy. When used for absorbed-dose mapping, simulated product is sometimes referred to as phantom material.
80
processing categories
* dimension of the process load
* weight of the process load
* density of the process load
* composition of the product
* orientation of the product items with the process load
* number of product items within the process load
* the required minimum dose
* the maximum acceptable dose
81
Process Interruption
The result of intentional or unintentional stoppage of the irradiation process. The process interruption and subsequent restart of the irradiation process can impact the absorbed dose delivered to the product.
82
Partially-Filled Irradiation Containers
During routine production, irradiation containers may not always be filled to their design limits or to what is defined to be a fullyloaded container configuration for a given product. This can impact the magnitude and
distribution of dose within the partially- filled container as well as within adjacent containers.
83
Center-loading of Product
Represents a unique way of loading product within
the irradiation container to improve (reduce) the dose uniformity ratio relative to that which would be achieved if the container were fully loaded with that product.
84
process parameters
irradiator timer settings or conveyor speed, electron beam energy, beam current, beam scan width, process load characteristics, process geometry, multiple exposure, multiple passes, partial loads, etc. In some electron beam irradiator designs, conveyor speed, beam current and beam scan parameters are linked and may be controlled as a combined parameter.
85
estimate of uncertainty
including those arising from calibration, dosimeter variability, instrument reproducibility, and the effect of influence quantities. A full quantitative analysis of
components of uncertainty is referred to as an uncertainty budget, and is then often presented in the form of a table. Typically, the uncertainty budget will identify all significant components of uncertainty, together with their methods of estimation, statistical distributions and magnitudes.
86
Absorbed Dose (D)
quantity of ionizing radiation energy imparted per unit mass of a specified material.
The SI unit of absorbed dose is the gray (Gy), where 1 gray is equivalent to the absorption of 1 joule per kilogram in the specified material (1 Gy = 1 J/kg). The
mathematical relationship is the quotient of dε by dm, where dε is the mean incremental energy imparted by ionizing radiation to matter of incremental mass dm.
87
Approved Laboratory
recognized by national metrology institute; or has been formally accredited to ISO/IEC 17025, or has a quality system consistent with the requirements of ISO/IEC 17025.
calibration laboratory accredited to ISO/IEC 17025 or its equivalent should be used for issue of reference
standard dosimeters or irradiation of dosimeters in order to ensure traceability to a national or international standard.
88
Average Beam Current
time-averaged electron beam current; for a pulsed accelerator, the averaging shall be done over a large number of pulses.
89
Beam Length
dimension of the irradiation zone along the direction of product movement at a specified distance from the accelerator window.
90
Beam Power
product of the average electron beam energy and the average beam current.
91
Beam Spot
shape of the un-scanned electron beam incident on the reference plane
92
Beam Width (Wb)
dimension of the irradiation zone perpendicular to the direction of product movement at a specified distance from the accelerator window
Beam width is perpendicular to the direction of motion of the conveyor. Beam width is the distance between two points along the dose profile, which are at a defined level from the maximum dose region in the profile
93
Continuous-Slowing-Down-Approximation (CSDA) Range (R0)
average path length traveled by a charged particle as it slows down to rest, calculated in the continuous slowing down-approximation method.
94
Depth-Dose Distribution
The depth-dose distribution is measured by irradiating dosimeters in a stack of plates of homogeneous material or by placing dosimeters or a dosimeter strip at an angle through a homogeneous absorber.
variation of absorbed dose with depth from the incident surface of a material exposed to a given radiation.
95
Duty Cycle
fraction of time the beam is effectively on.
| Duty cycle is the product of the pulse width (w) in seconds and the pulse rate (f) in pulses per second.
96
Electron Beam Energy
kinetic energy of the accelerated electrons in the beam.
Unit of Measurement: J
```
Electron volt (eV) is often used as the unit for electron beam energy where 1 eV = 1.602 x 10-19 J. In radiation processing, where beams with a broad electron energy
spectrum are frequently used, the terms most probable energy (Ep) and average energy (Ea) are common. They are linked to the practical electron range Rp and half-value depth R50 by empirical equations.
```
97
Electron Beam Facility
establishment that uses energetic electrons produced by particle accelerators to irradiate product.
98
Electron Beam Range
penetration distance in a specific, totally absorbing material along the beam axis of the electrons incident on the material.
99
Electron Energy Spectrum
particle fluence distribution of electrons as a function of
| energy.
100
Extrapolated Electron Range (Rex)
depth in homogeneous material to the point where
the tangent at the steepest point (the inflection point) on the almost straight descending portion of the depth-dose distribution meets the depth axis.
101
Half-Entrance Depth (R50e)
depth in homogeneous material at which the absorbed
| dose has decreased to 50 % of its value at the entrance surface of the material
102
Half Value Depth (R50)
depth in homogeneous material at which the absorbed dose has decreased to 50 % of its maximum value
103
Optimum Thickness (Ropt)
depth in homogeneous material at which the absorbed dose equals its value at the entrance surface of the material.
104
Production Run
of process loads consisting of materials or products having similar radiation-absorption characteristics, that are irradiated sequentially to a specified range of absorbed dose.
105
Reference Plane
selected plane in the radiation zone that is perpendicular to the electron beam axis.
106
Standardized Depth (Z)
thickness of the absorbing material expressed as the mass per unit area, which is equal to the product of depth in the material t and density ρ.
If m is the mass of the material beneath area A of the material through which the beam passes, then:
z = m/A = tρ
The SI unit of z is in kg/m2, however, it is common practice to express t in centimeters and ρ in grams per cm3, then z is in grams per square centimeter. Standardized depth may also be referred to as surface density, area density, mass-depth or massthickness.
107
Dose as Function Of Average
Dose to the product irradiated in an electron beam facility is proportional to average beam current (I), and inversely proportional to conveyor speed (V) and to beam width (Wb), for a given electron beam energy. This relationship is valid for product that is conveyed through the radiation zone perpendicular to the beam width.
```
Dose = (K * I) ⁄ (V * Wb)
• D = Absorbed dose (Gy),
• I = Average beam current (A),
• V = Conveyor speed (m s-1),
• Wb = Beam width (m), and
• K = Slope of the straight line relationship in (Gy *m2)/(A* 2).
```
108
Requalification
Requalification is typically carried out on an annual cycle, with specific parts of requalification at shorter time intervals within this cycle. If requalification measurements show that the irradiator has changed from previous OQ measurements, then PQ might have to be repeated.
109
loading pattern
A dimensions and bulk density of the process load,
B composition of product and all levels of packaging,
C orientation of the product within its package, and
D orientation of the product with respect to the material
handling system and beam direction.
110
FPM
Feet per Minute
111
FPM Curve
f(Frequency)
112
RPM
Revolutions/Rotations per Minute
113
Tachometer
Instrumentation utilized to determine RPM, either fixed or movable
114
VFD
Variable Frequency Drive
115
External Training
training completed with or through the utilization of external resources
116
Internal Training
training completed without the utilization of external resources
117
Safety Training
internal or external training that provides personnel with instruction related to the prudent operation of equipment or completion of a task
118
Training Plan
documented procedure for facility operators and staff to successfully complete their respective Training Requirements, the approved schedule within which the
training elements can be completed, and the defined means through which the training will be
completed, verified, and maintained
119
Training Requirements
required education and instruction that is mandatory prior to personnel assuming a role
120
ISPM18
International Standards for Phytosanitary Measures
Guidelines for the use of irradiation as a phytosanitary measure
121
IPPC
International Plant Protection Convention
122
FAO
Food and Agriculture Organization of the United Nations
