PDA TR-20-1990 行业现行更衣规范调查报告 Report on Survey of Current Industry Gowning Practices

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223-22744, 1990 PDA J Pharm Sci and Tech

Gowning Task Force

Report on Survey of Current Industry Gowning Practices: PDA

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ASSOCIATION COMMENTARY

Report on Survey of Current Industry Gowning Practices

PDA Gowning Task Force

Parenteral Drug Association

ABSTRACT:

A survey of selected member companies of the PDA was taken by the Gowning Task Force to

determine gowning practices within the Parenteral drug industry.

Task Force Members

Robert F. Sohn, Chairman

Eli Lilly and Company, Indianapolis, IN

James P. Akers

Praxis Biologies, Inc., Sanford, NC

Daniel H. Gold

Lederle Labs, Pearl River, NY

Benjamin Goodwin

Angelica Uniforms, St. Louis, MO

Jean Woods

Collagen Corporation, Palo Alto, CA

William Whyte, Corresponding member, University of

Glasgow, Glasgow, Scotland

The Quality Assurance subcommittee of the PDA Re-

search Committee commissioned the Gowning Task

Force to undertake a survey of industry gowning prac-

tices.

It deals with the "Selection of Aseptic Area Outer-

wear," "Assuring Sterility of Outerwear Used," "Deter-

mining Continued Suitability," "Donning of

Gloves,"

and

"Monitoring Employee Gowning Practices."

This survey was distributed to sixty-five members of the

PDA involved in parenteral drug manufacturing. A total

of 26 forms were completed and returned anonymously.

The following is the summary of the completed responses.

Results

PDA Gowning Task Force—Industry Survey

I. Selection of Aseptic Area Outerwear

Who selects the garments to be worn?

a) Purchasing 4

b) Production 19

c) Quality Assurance 10

d) Other (specify): 4

QC(1)

Group Leader

and

Staff of Parenteral Clinical Area (

)

Parenteral Formulations (1)

Area utilizing garment (1)

What is the basis for garment selection? Rank by order of

preference (1-5) with

highest. 1st 2nd 3rd 4th 5th

a) Garment permeability or

filtration efficiency 9 8 3 0 2

b) Wearer comfort 7 4 3 7 3

c) Fabric durability 11 7 3 11

d) Details of construction 14 7 10 2

i) Seams 5 1

ii) Closures 3 3

e) Particulate/fiber generation 10 9 4 0 0

0 Other (specify) 4 0 0 2 1

1st—Overall design

—Sterility assurance & certification

—To envelope personnel

—Overall system and controls

4th—Able to rewash and resterilize

—Ease of sterilization

5th—Price

If permeability of filtration efficiency is basis, what

criteria are used for:

a) Fabric pore diameter 9

b) Air permeability rate 1

c) Other (specify): 3

Vendor certification (1)

Comfort (1)

Particulate testing during uniform evaluation (10)

d) N/A 13

2a2.

If specific criteria are in use for permeability, does:

firm determine 5

vendor data used 10

N/A 11

If wearer comfort is an issue, how is this evaluated?

a) Actual use test by firm 19

b) Simulate use test 2

c) Accept vendor presentation of

acceptability by other firms 5

d) Other (specify) 0

e) N/A 2

2b2.

For recycled garments, what is firm's expectation of

expected garment life?

cycles 7

cycles 3

c) 50 cycles 3

Correspondence

address:

Mr. Robert F. Sohn, Task Force Chairman,

Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN

46285.

223

Vol.

44,

No.

4 / July-August 1990

on February 1, 2015journal.pda.orgDownloaded from

d) 100 cycles 4

e) 200 cycles 0

f) Other (specify): 6

Appearance

( 1

)

Not determined (2)

200 cycles (1)

As determined by vendor's rotation (1)

Nylon, 200 cycles expected (1)

g) N/A 3

Garment construction requirements. Check all that apply.

a) Overlapping of fabric at seams 12

b) Double stitching at seams 17

c) Zipper closure 25

d) Button closures 2

e) Velcro closures 1

f) Elastic bands at wrists and legs 12

g) Snap closures at wrists and legs 14

h) Velcro closures at wrists and legs 1

i) Other (specify): 2

Adjustable hoods for proper fit (I)

Snap closures for hoods

( 1

)

2el.

Does firm examine a sample of proposed new garment

after first washing for loose particulates/fibers?

Yes 8 No 16

If yes, is examination:

i) Via microscopy 2

ii) Via passing liquid or air through fabric and

collection of particulates/fibers on filter 4

¡ii) Other (specify): 2

Visual inspection for gross fibers (1)

Visual check (1)

N/A 1

Who selects gloves to be worn?

a) Purchasing 3

b) Production Supervisor 20

c) Quality Assurance 6

d) Other (specify): 3

QC(1)

Group leader and staff of Parenteral Clinical Area (1)

Parenteral Formulations

( 1

)

Are gloves selected normally:

a) Double bagged Yes 13 Noll N/A 1

b) Interior dusted Yes 8 No 15 N/A 2

c) Cuffs folded Yes 24 No 1 N/A 0

d) Wrist length Yes 11

Forearm length Yes 13

N/A 1

What thickness gloves normally specified?

0.007 mils 3

7 mils 3

7-9 mils 1

9 mils 1

0.4 mils 1

0.5 mils 1

2 mils 1

N/A 14

6a. Are face masks used in critical areas?

Yes 24 No 0 N/A 0

6b.

yes,

do they provide essentially full face coverage?

Yes 21 No 4 N./A 0

6c.

Are goggles or eye shields used to reduce fa<¿e exposure

further?

Yes 21 No 4 N/A 0

II.

Donning of Gloves

In gowning procedures followed in your firm, which practice

most closely describes procedures followed?

a) Gloves donned last 7

i) Operator sanitizes hands

ii) Operator dons garments

iii) Operator dons sterile gloves

b) Gloves donned first 5

i) Operator dons sterile gloves

ii) Operator dons garments

iii) Operator sanitizes gloves

c) Gloves donned first and last 13

i) Operator dons sterile gloves

ii) Operator dons garments

iii) Operator replaces sterile gloves with

new pair or dons 2nd pair over first

lai.

If practices followed at your firm differ significantly

from any described above, please provide details.

What type of antiseptic agent is employed for:

Hands Gloved Hands

Bactoshield 70% Isopropanol

Aleare Aleare

Aleare (Calgon Vestal Alcohol (Sterile)

Foamed Alcohol)

Liquid Detergent None

Foam Alcohol Sterile filtered 70% IPA

Aleare Aleare & Quat. Sol.

Disinfectant Soap Alcohol (90%)

Iodine Sol. 70% IPA

Antiseptic antimicrobial 0.2mm filtered 70% IPA

skin cleaner

SBS-72 Jergens Alcohol

Aleare Aleare, 70% filtered IPA

N/A 70% filtered Ethyl Alcohol

Antiseptic soap Foamed Alcohol

None Sodium Hypochlorite

N/A 70% EtOH

Betadyne surgical scrub Alcohol Foam

Betadyne Aleare

Aleare Alcohol

Iodopor 70% Alcohol

Septisol Septisol and IPA

Aleare Aleare

Soap L.P.H. or Vesfen

Vestal Lph or Glutarex

Hibiclins Benzalkonium chloride, Valiant

and water wash, then A.B.C,

solution

Septisol Phenol Alcohol

III.

Determining Continued Suitability of Aseptic Area Outer-

wear

What criteria are used for determining continued suitability

of outerwear?

a) Time dating with cutoff Yes 5 No 10 N/A 10

If yes, is this based on

quantitative data YesO No 3 N/A 2

yes,

report basis

b) Cycle tracking with cutoff Yes 3 No 12 N/A 10

yes,

is this based on

quantitative data Yes

No 2

yes,

report basis: N/A

224 Journal of Parenteral Science & Technology

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摘要：

本文档全面回顾了PDA TR-20-1990《行业现行更衣规范调查报告》，该报告由美国注射剂协会（PDA）发布，旨在系统调查和总结20世纪90年代初期制药与生物技术行业中无菌生产区域的更衣实践。报告基于行业广泛调研，详细分析了不同企业采用的更衣程序、更衣室设计、洁净服材质选择、更衣验证方法以及人员行为规范，并指出了当时存在的共性问题与最佳实践。作为PDA技术报告系列的早期重要文献，TR-20-1990为后续更衣标准（如ISO 14644及相关PDA报告）的制定奠定了数据基础。对于从事无菌工艺、G

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