YY/T 1302.1-2015 English PDF (YYT1302.1-2015)

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YY/T 1302.1-2015: Physical requirements and microbiological performance of ethylene oxide sterilization - Part 1: Physical aspects
YY/T 1302.1-2015
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
Physical requirements and microbiological
performance of ethylene oxide sterilization -
Part 1: Physical aspects
ISSUED ON: MARCH 02, 2015
IMPLEMENTED ON: JANUARY 01, 2016
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 4 
4 Equipment for ethylene oxide sterilization process ... 5 
5 Determine the minimum temperature of product before preconditioning ... 12 
6 Calculate humidity ... 14 
7 Calculation of ethylene oxide concentration ... 17 
8 Calculation by the use of flammability curves ... 19 
9 Guide to statistical contrast methods for determining process equivalence 20 
Appendix A (Informative) An example of a method for determining the
concentration of ethylene oxide gas based on the physical formula of an ideal
gas ... 26 
Appendix B (Informative) Calculation example using a flammability curve ... 29 
Physical requirements and microbiological
performance of ethylene oxide sterilization -
Part 1: Physical aspects
1 Scope
This part of YY/T 1302 specifies the physical requirements for the sterilization
of ethylene oxide.
This part is intended to provide guidance for sterilization equipment,
preconditioning, calculation of relative humidity, concentration of ethylene oxide,
flammability, statistical applications in process equivalents.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this standard.
GB 3836.1-2010 Explosive atmospheres - Part 1: Equipment - General
requirements
GB 3836.14-2014 Explosive atmospheres - Part 14: Classification of areas
- Explosive gas atmosphere
GB 50169-2006 Code for construction and acceptance of grounding
connection electric equipment installation engineering
GBZ 2.1-2007 Occupational exposure limits for hazardous agents in the
workplace Part 1: Chemical hazardous agents
ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide -
Part 1: Requirements for development, validation and routine control of a
sterilization process of medical devices
3 Terms and definitions
The terms and definitions as defined in ISO 11135-1:2007 as well as the
following terms and definitions apply to this document.
GB 3836.14-2014;
b) The interior of the sterilizing cabinet shall also comply with the
requirements or equivalent requirements of the category T2 electrical
equipment in the zone IIB0 in GB 3836.1-2010 and GB 3836.14-2014;
c) Equipment and piping shall comply with the grounding requirements of GB
50169-2006 or other equivalent requirements;
d) The storage, disposal, use of ethylene oxide shall comply with relevant
national regulations;
e) When designing the sterilization cycle, the environment inside the
sterilizing cabinet shall be kept non-flammable.
4.1.2 Under abnormal conditions (such as equipment failure, power interruption,
test cycle, etc.), when the product is exposed to an ethylene oxide sealed
environment and lack proper ventilation (failure of air exhaust or ventilation
equipment, etc.), it shall pay attention to the hazard as caused by the
accumulation of the flammable and explosive ethylene oxide. The possibility of
this hazard is independent of the mixture used.
4.1.3 Fume hoods or ventilation areas (buildings, rooms) shall be equipped with
equipment that removes sterilized gases and restores them to a safe level (see
GBZ 2.1-2007).
4.1.4 For electromagnetic interference as caused by the equipment or
environment or both inside the workshop (such as a mobile phone) or outside
the workshop, it shall evaluate the impact on the sterilization process. When
designing the plant, it shall comprehensively consider the infrastructure
(appropriate grounding, shielded cables, circuit isolation, protective building
materials, etc.), to avoid interference with the sterilization process.
Note: For guidance on electromagnetic interference, see GB/T 17799.
4.2 Preconditioning area (outside sterilizing cabinet)
4.2.1 If the product is heated and humidified in the workshop, there shall be
equipment to adequately control and record the room temperature and humidity.
In ISO 11135-1:2007, humidity is only expressed in terms of relative humidity.
Humidity may also be recorded in other engineering units, such as dew point,
absolute humidity, water vapor pressure.
4.2.2 It shall use supporting air circulation to meet the requirements for the
temperature and humidity control and its distribution as specified in the
available rooms (areas).
4.2.3 During identification of equipment, it shall establish and record the air
4.3.4 It shall select the sensors which are suitable for the ethylene oxide
sterilization process (such as pressure, temperature, gas concentration, relative
humidity sensors, etc.).
4.3.5 If there is a deviation in the sterilization process, it shall use audible and/or
visual alarm to alarm the operator.
4.3.6 Sterilizing cabinets shall be mechanically (interlocked) designed to
prevent inadvertent contact loading prior to the completion of the sterilization
cycle. If the sterilization cycle fails, it shall be limited only to understanding the
fault condition and the employee contact loading which may has risk.
4.3.7 When the sterilizing cabinet is used to condition the product loading
(regardless of static or dynamic), it shall be able to adequately control and
record the sterilizing cabinet’s temperature, pressure, other parameters to
achieve the desired process conditions.
4.3.8 Since the process conditions within the sterilizing cabinet may reach the
dew point of the water, it shall evaluate the condensate on products and
equipment. In particular, the condensate at cold point will reduce the partial
pressure of water vapor in the sterilizing cabinet, resulting in additional steam
injection to maintain a constant pressure under static processing conditions.
Excessive condensate in the sterilizing cabinet or on the product/package will
impede the killing effect of ethylene oxide gas on the microorganism of the
product; meanwhile it will adsorb ethylene oxide gas and ethylene oxide
derivative. The adsorbed ethylene oxide gas will diffuse when the product
loading is ventilated or stored, endangering the health of the staff. In addition,
the condensate in the sterilizing cabinet or on the product load will re-evaporate
and make the humidity level in the headspace of the sterilizing cabinet exceed
the confirmed level.
4.3.9 For equipment designed to heat and humidify, the sterilizing cabinet shall
avoid direct humidification of the product loading (such as the use of manifolds
or partitions). Generally, it uses steam valves, traps and/or coalescing filters to
control the quality of the steam which enters the sterilizing cabinet. Steam water
shall not contain contaminants that affect the sterilization process or damage
the sterilizing cabinet or sterilized load.
4.3.10 It shall select the equipment that has sufficient control over the
parameters as provided and as selected by the monitoring, such as:
a) Pressure control;
b) Rate control (such as exhaust or gas injection);
c) Temperature control;
4.3.14 The distribution of temperature, humidity, sterilization gas shall comply
with the requirements of the sterilization process. It shall specify the available
sterilizing cabinet’s boundaries and product loading dimensions, to eliminate
the adverse effects due to too closeness of sterilized loading of the product and
the interior walls of the cabinet. These effects may include gas circulation
problems due to product’s obstruction, uneven heating of product loading due
to direct contact to cabinet wall as well as the interference of product to the
process monitoring instrument.
4.3.15 It shall use the infrastructure and/or engineering controls to ensure the
specified steam, appropriate gas, air and/or nitrogen are injected into the
cabinet.
4.3.16 It shall configure nitrogen and air injection filters to protect products and
equipment. If compressed air is in contact with the product, the air shall be
protected or treated, to ensure it is dry, oil-free and filtered.
4.3.17 When sterilizing products that do not contain protective packaging, it
shall follow the quality system of the manufacturer to configure sterilizing filter.
4.4 Ventilation system
4.4.1 After gas exposure, if using a room/zone/cabinet to ventilate the product,
it shall be equipped with equipment which continuously control and record the
air temperature. It shall be equipped with facilities which regularly check the air
flow and/or ventilation rate during the ventilation period, to verify compliance
with the originally validated performance specifications. If fresh air flows into
and out of the room/zone/cabinet changes, the temperature distribution of
room/zone/cabinet may exceed the confirmed tolerances. This will affect the
proper resolution of the ventilation product and/or the problem of employee
exposure to hazards.
4.4.2 The specified limits for the accuracy and reproducibility of measuring
instruments used in the ventilation process shall be in accordance with the
process requirements.
4.4.3 Ventilation rooms/zones/cabinets shall be easy to clean. The construction
materials are adapted to the cleaning process. In accordance with good
hygienic practices and manufacturer-defined procedures, carry out the cleaning
process.
4.4.4 It shall be equipped with facilities that identify the loading of different
products in the ventilated room/zone/cabinet.
4.4.5 In the event of a deviation, it shall use an audible and/or visual alarm to
prompt the operator.
n) Systems that supply steam and heat;
o) Vacuum equipment;
p) Weighing system;
q) Valve;
r) Pressure transmitter;
s) Timer;
t) Printer.
4.7 Safety
4.7.1 It shall use ethylene oxide gas with caution, because it is toxic, potentially
flammable, explosive. When selecting ethylene oxide sterilization and
ventilation equipment, it shall comply with national health and environmental
protection regulations.
4.7.2 It shall carry out risk assessment (sch as batteries and capacitors) on any
product which contains energy-storing components.
4.7.3 The exposure to ethylene oxide in the workplace shall comply with the
occupational exposure levels of GBZ 2.1-2007.
5 Determine the minimum temperature of product
before preconditioning
5.1 Overview
5.1.1 In 9.5.4 a) 2) of ISO 11135-1:2007, it requires determining the minimum
temperature of the product before starting preconditioning. The loading
temperature before entering the preconditioning shall be determined in the
coldest zone. When the product which was too cold after placement enters
preconditioning, it shall dispose it with caution. Sudden changes in temperature
may cause product damage and/or large amounts of condensed water.
5.2 Simulation of expected process conditions
5.2.1 Process validation shall consider the most difficult sterilizing conditions to
be expected for loading. It shall evaluate the effects of loading temperature
limits on the sterilization process during transportation, handling, storage.
These expected loading temperature limits can be simulated at the time of
validation by including, but not limited to, the following methods:
is established during process validation. In monitoring and controlling
conventional production, each load shall be temperature probed prior to
preconditioning and compared to the value verified at the time of validation. Any
loading that does not meet the minimum requirements shall be maintained in
the storage area until the coldest load meets the specified requirements.
5.4.2 Hard-to-heat loading
It shall be specified that before entering the preconditioning zone or the
sterilizing cabinet, the product loading shall reach the minimum acceptable
temperature. This is especially important for loads that are difficult to heat or
that enter into the preconditioning zone below the dew point temperature or that
are preconditioned by a sterilizing cabinet. In all loads, the zone which shows
the lowest temperature will receive sufficient microbial challenges.
6 Calculate humidity
6.1 Static humidification
6.1.1 Process definition
Usually after being loaded in a sterilizing cabinet to subject to the vacuum
process, it designs a process to add or replenish the moisture and heat of the
load. When statically humidified, steam is injected into the sterilizing cabinet to
achieve a desired partial pressure and obtain a desired relative humidity level.
In most systems, because the load absorbs a large amount of the injected
moisture, in the steam holding stage of the sterilizing process, the control
system automatically controls the pressure of the sterilizing cabinet by
increasing steam injection. It may control the rate of steam injection to enhance
the effect of steam injection. Taking the injection rate control measures will allow
sufficient time for the steam to penetrate into the load, thereby resulting in better
heating and heat distribution effects.
6.1.2 Design a static humidification process
6.1.2.1 Low-vacuum process
It is used to sterilize loads that may contain pressure sensitive materials or
instruments. These processes often employ vacuum levels of about half
atmospheric pressure. In addition, use a lower vacuum rate to minimize the
effects of pressure changes on vacuum sensitive materials or instruments.
Using a low-vacuum level. During the initial vacuuming stage of the sterilization
cycle, most of the heat and moisture inside the product load remains in the load,
which requires little replenishment. The moi...