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GB/T 36030-2018: General technical requirements of CIP and SIP for pharmaceutical machinery
GB/T 36030-2018
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.120.30
C 90
General technical requirements of CIP
and SIP for pharmaceutical machinery
ISSUED ON. MARCH 15, 2018
IMPLEMENTED ON. OCTOBER 01, 2018
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China;
Standardization Administration of the People's Republic of
China.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 General ... 5
5 Cleaning and sterilization in place system materials ... 7
6 Cleaning and sterilization in place system surface quality ... 7
7 Cleaning and sterilization in place system structure ... 7
8 Cleaning ... 8
9 Sterilization ... 13
10 Sampling ... 14
11 Validation ... 14
12 Cleaning and sterilization quality standards ... 16
13 Cleaning and sterilization quality test methods ... 17
Bibliography ... 18
General technical requirements of CIP
and SIP for pharmaceutical machinery
1 Scope
This Standard specifies the general technical requirements for pharmaceutical
machinery implementing cleaning in place and sterilization in place in the “Good
Manufacturing Practice (2010 Revision)”.
This Standard is applicable to the pharmaceutical machinery implementing
cleaning in place and sterilization in place during the pharmaceutical production
process.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB 28670 General rule of pharmaceutical machinery conforming to good
manufacturing practice
JB/T 20158 Pharmaceutical cleaning in place equipment
Quality Management Regulations for Pharmaceutical Production (revised in
2010) (Ministry of Health of the People's Republic of China)
Pharmacopoeia of the People's Republic of China (2015 Edition) (National
Pharmacopoeia Commission)
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
cleaning in place; CIP
Cleaning of system or equipment in the original installation position, without
disassembling or moving.
GB 28670.
4.2 The CIP and SIP process shall be effective and reproducible, and the data
shall be traceable.
4.3 The installation environment, location and space, floor structure and
process piping of CIP and SIP for pharmaceutical machinery shall meet the
requirements of CIP and SIP process and validation.
4.4 The validity of the process certification documents and batch record
documents shall be confirmed before implementing CIP and SIP for
pharmaceutical machinery.
4.5 The CIP pharmaceutical machinery shall be cleaned at the specified time
after used. Non-sterile drug production equipment shall be dried after cleaning;
sterile drug production equipment and aseptic operation area production
equipment shall be sterilized at the specified time after cleaning. The exposed
opening after cleaning, sterilization and drying shall be closed.
4.6 Sterile drug production equipment shall be sterilized after complete
assembly. Equipment, pipes, connecting points, valves, and sealing devices
that are in direct contact with the materials should be cleaned in place and
sterilized in place.
4.7 CIP shall ensure that there is no dead space in the cleaning range. The
cleaning solution pressure, flow rate, temperature, and cleaning time shall be
guaranteed and verified before implementation.
4.8 For CIP pharmaceutical machinery which is difficult to determine the residue
limit standard, the surface in contact with the material shall be sprayed with the
specified drug. After cleaning, the residue limit of the sprayed drug shall be
used as the validation index.
4.9 The type of cleaning agent used in CIP pharmaceutical machinery, the
concentration of cleaning fluid, and the order of use shall be verified before
putting into use.
4.10 Pharmaceutical machinery cleaned with acidic or alkaline water shall have
a sewage disposal facility.
4.11 Pharmaceutical machinery cleaned with organic solvents shall have an
explosion-proof facility.
4.12 The validation of CIP devices consisting of one or more systems shall
include microbial challenge tests under the most adverse conditions.
4.13 Sterile drug production equipment and aseptic operation area production
The minimum limit value calculated by one of the above three methods is taken
as the acceptance standard for the residue per unit area by wipe sampling.
8.1.12 It shall make clear the dry storage conditions after cleaning.
8.1.13 It shall make clear the validity period after cleaning.
8.1.14 The cleaning procedures shall be able to guide each operator to work.
8.2 Selection of cleaning agent
8.2.1 The cleaning agent shall have simple composition, stable quality and
exact effect.
8.2.2 The cleaning agent shall dissolve the residue effectively, not corrode the
equipment, and be easily removed. The recovery rate shall not be less than
50 %.
8.2.3 The biological activity or toxicity parameters in the cleaning agent shall be
clear.
8.2.4 The cleaning agent shall be environmentally friendly or harmless.
8.2.5 The name, formula and operating parameters of the cleaning agent shall
be determined according to factors such as residue’s solubility, activity or
toxicity, stability, viscosity, adsorption, concentration of the active ingredient,
daily dose range, production batch, influence of auxiliary materials on cleaning
effect, chemical compatibility of cleaning materials and cleaning agents.
8.2.6 The selection of the cleaning agent shall avoid introducing new impurities.
8.2.7 For cleaning agents that need to be recycled, the quality of the recycled
cleaning agent shall be monitored and proved to have no adverse effect on the
quality of the drug.
8.2.8 In order to prevent the cleaning agent from causing tolerance to spores
and microorganisms, the cleaning agent shall be replaced regularly.
8.2.9 The cleaning water shall meet the quality standards for pharmaceutical
water as specified in the Pharmacopoeia of the People's Republic of China.
The condensed water of pure steam shall meet the quality standards for
pharmaceutical water as specified in the Pharmacopoeia of the People's
Republic of China. The last cleaning water for sterile pharmaceutical equipment
shall be water for injection, and the last cleaning water for non-sterile
pharmaceutical equipment shall be at least purified water.
8.3 Determination of cleaning parameters
9 Sterilization
9.1 Sterilization procedures
9.1.1 It shall make clear the interval between the end of the cleaning and the
start of sterilization.
9.1.2 It shall make clear the method of sterilization.
9.1.3 It shall make clear the location of the coldest spot and use the table or
icon to indicate the location of the temperature probe and indicator.
9.1.4 It shall make clear the name and requirements of biological indicator.
9.1.5 It shall make clear the procedure for sterilization.
9.1.6 It shall make clear the quality requirements for sterilization media.
9.1.7 It shall make clear monitor the instrumentation and accuracy
requirements of the sterilization parameters and have a calibration record.
9.1.8 It shall make...