GB/T 16293-2010 PDF English
US$225.00 · In stock · Download in 9 secondsGB/T 16293-2010: Test method for airborne microbe in cleanroom (zone) of the pharmaceutical industry Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid GB/T 16293: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB/T 16293-2010 | English | 225 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Test method for airborne microbe in cleanroom (zone) of the pharmaceutical industry
| Valid |
| GB/T 16293-1996 | English | 319 |
Add to Cart
|
3 days
|
Test method for airborne microbe in clean room (area) of the pharmaceutical industry
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: GB/T 16293-2010
GB/T 16293-2010: Test method for airborne microbe in cleanroom (zone) of the pharmaceutical industry
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT16293-2010
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.040.30
C 30
Replacing GB/T 16293-1996
Test method for airborne microbe in
cleanroom (zone) of the pharmaceutical industry
Issued on. SEPTEMBER 02, 2010
Implemented on. FEBRUARY 01, 2011
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
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 Test methods... 5
5 Test rules... 9
Annex A (Normative) Sampling point layout in cleanroom (zone)... 13
Annex B (Normative) Sterilization and preparation of the medium... 15
Annex C (informative) Technical requirements for airborne microbe in
cleanroom (zone)... 17
1 Scope
This Standard specifies the test conditions, test methods for airborne microbe
in cleanroom (zone) of the pharmaceutical industry.
This Standard is applicable to the verifications of test and environment for
airborne microbe in cleanroom and clean zone in the pharmaceutical industry,
sterile room or partial air purification area (including clean bench).
2 Normative references
The following standards contain the provisions which, through reference in this
Standard, constitute the provisions of this Standard. For dated references,
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
GB/T 16292-2010, Test method for airborne particles in clean room(zone) of
the pharmaceutical industry
JGJ 71-1990, Code for Construction and Acceptance of Cleanroom
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 colony forming units
Microbial colonies formed by one or several microorganisms after microbial
culture, referred to as CFU; usually expressed in numbers.
3.2 airborne microbe
Number of colonies that it collects live microbial particles suspended in air by
the methods mentioned in this Standard, through specialized medium, breeding
to visible under suitable growth conditions.
3.3 airborne microbe concentration
The number of colonies containing airborne microbe per unit volume of air,
expressed in terms of counting concentration, the unit is number/m3 or /L.
3.4 action levels
For controlled cleanroom (zone), the user sets the microbial content level by
the user. When the test result exceeds this level, the monitoring program shall
be initiated to immediately track the microbial contamination of the area.
3.5 alert levels
For a controlled clean room (zone), the user sets a microbiological content level,
giving a bias value that is the earliest alert compared to the normal state. When
the deviation value of the earliest warning is exceeded, procedures and related
measures to ensure that the process or environment are not affected shall be
initiated.
4 Test methods
4.1 Method summary
The method used in this Standard is the counting concentration method, that is,
by collecting biological particles suspended in the air in a special medium
(selecting a medium that can confirm the growth of the microorganisms).
4.2 Staff duties and training
Testers in cleanroom (zone) shall be trained in the profession and qualified to
perform their duties in cleanroom (zone) testing, including the health knowledge
and basic microbiological knowledge involved.
4.3 Instrument, auxiliary equipment and medium
Choose a suitable airborne microbe sampler, including an oil-free pump, lower
airflow rate and larger sample flow rate so as to ensure that the moisture on the
surface of the medium is not dried.
4.4 Principle of airborne microbe sampler
The airborne microbe sampler generally uses the impact mechanism. It can be
divided into slit sampler, centrifugal or pinhole sampler. The slit sampler draws
in the airflow from the internal fan and sprays the collected air through the slit
plate of the sampler onto the surface of the slowly rotating plate medium;
attached live microbial particles are cultured to form colonies.
4.5 Test points
4.5.1 The instrument must be periodically verified according to the test cycle of
the test instrument. Use instrument that passes the verification and is in use.
4.6 Petri dish
4.6.1 Generally use a petri dish of φ90mm×15mm size. Select the appropriate
dish according to the selected sampler.
4.6.2 Centrifugal sampler uses dedicated solid culture strip.
4.7 Medium
Trypticase soy agar medium (TSA) or Sabouraud dextrose agar medium (SDA)
or other user-approved and validated medium. See Annex B for preparation
method.
4.8 Constant temperature incubator
The constant temperature incubator must be checked regularly.
4.9 Test procedures
4.9.1 The surface of the instrument and the culture dish must be strictly
disinfected before the test.
4.10 Cultivation
4.10.1 After all sampling is completed, the culture dish is placed in a constant
temperature incubator for cultivation.
4.10.2 The culture dish prepared by Trypticase soy agar medium (TSA) is
sampled and cultured in an incubator at 30°C ~ 35°C for at least 2d; the culture
dish prepared in Sabouraud dextrose agar medium (SDA) is sampled and
cultured in an incubator at 20°C ~ 25°C for at least 5d.
4.10.3 Each batch of mediums shall have a control test to check whether the
medium itself is contaminated. 3 culture dishes can be selected for each batch
for control culture.
4.11 Count of colony forming units
4.12 Precautions
4.12.1 The quality of each culture dish shall be carefully checked before use. If
culture medium and culture dish may be deteriorated, damaged or
contaminated, they cannot be used.
4.12.2 Make detailed recording of media, culture conditions and other
parameters.
4.12.3 Due to the wide variety of bacteria, the difference is very large. When
counting, generally use the transmitted light to observe carefully on the back or
front of the dish. Do not miss the colonies growing on the edge of the dish. And
pay attention to the difference between bacterial colonies or medium sediments.
Use microscopic identification if necessary.
5 Test rules
5.1 Test conditions
Pre-test the relevant parameters of the cleanroom (zone) before testing. Such
tests shall provide environmental conditions for testing airborne particles, such
as. such pre-tests may include.
5.2 Test state
Both at-rest and operational-state can be tested.
No more than 2 indoor testers during at-rest testing.
Before the airborne microbe test, the cleanroom (zone) to be tested is
determined by the user, whether it needs to be pre-sterilized.
The test report shall indicate the state of the test and the number of indoor
testers.
5.3 Test time
5.3.1 In the case of as-built or at-rest a test, for a unidirectional flow cleanroom
(zone), the test shall begin after the normal operation time of the purified air
conditioning system is not less than 10min. For non-unidirectional flow
cleanroom (zone), the test shall start after the normal operation time of the
purified air conditioning system is not less than 30min. In the at-rest b test, for
the unidirectional flow cleanroom (zone), the test shall be started after the
production operator evacuates the site and after 10min of self-cleaning. For
non-unidirectional flow cleanroom (zone), the test shall be started after the
production operator evacuates the site and after 20min of self-cleaning.
5.3.2 In operational test, it must record the start of production and test time.
5.4 Calculation of airborne microbe concentration
5.4.1 Number of sampling points and their layouts
5.4.1.1 Number of minimum sampling points
The number of minimum sampling points for the airborne microbe test can refer
to GB/T 16292-2010.
5.4.1.2 Location of sampling point
The sampling point location of airborne microbe can refer to GB/T 16292-2010.
5.4.2 Minimum sampling amount
See Table 1 for each minimum sampling amount of airborne microbe.
5.4.3 Number of samplings
Each sampling point is typically sampled once.
5.4.4 Sampling considerations
5.5 Recording
The test report shall contain the followings.
5.6 Calculation of result
5.6.1 Count the number of colonies in each dish by counting.
5.6.2 For the calculation of the average concentration of airborne microbe at
each measuring point, see formula (1).
5.7 Result evaluation
5.7.1 The average concentration of airborne microbe at each measurement
point must be below the limit in the selected assessment criteria.
5.7.2 In the at-rest test, if the average concentration of airborne microbe at a
certain measuring point exceeds the evaluation standard, it shall be re-sampled
twice, and the two test results are all qualified before they can be determined
as conforming.
5.8 Daily monitoring
For the monitoring of airborne microbe, it is advisable to set the airflow with a
uniform wind speed in the cross section of the cross-flow line in the single
direction and the direction of the airflow to ensure the microbial concentration
of the cleanroom (zone) is controlled. It shall be regularly tested to check the
microbial load and the effectiveness of the disinfectant, and to analyze the
propensity. Both at-rest and operational monitoring can be used.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of GB/T 16293-2010 be delivered?Answer: The full copy PDF of English version of GB/T 16293-2010 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice. Question 2: Can I share the purchased PDF of GB/T 16293-2010_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 16293-2010_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- GB/T 16293-2010 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. Question 5: Should I purchase the latest version GB/T 16293-2010?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 16293-2010 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. How to buy and download a true PDF of English version of GB/T 16293-2010?A step-by-step guide to download PDF of GB/T 16293-2010_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "GB/T 16293-2010".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9
|