QAS-003 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 208

Biomedical Engineering Reference

In-Depth Information

(conti nued)

after visual

inspection

for liquid-

borne

Particulate

matter

f. chemical

bulk after leak

test autoclave

lyophilization

micro f. bulk

after leak test

autoclave

lyophilization

chemical

bulk

(g/ml)

s.

no.

contai-

ner

contai-

ner

contai-

ner

contai-

ner

contai-

ner

Product name

micro bulk (g/ml)

Physical

19.

ENOXIRT 0.25 g

IM

-

-

-

-

-

-

-

-

Pack size 1s

5 boxes

-

10 Vials

20.

ENOXIRT 0.25 g

IV injection

-

-

-

-

-

-

-

-

Pack size 1s

5 boxes

-

10 Vials

21.

ENOXIRT 0.5 g

IM

-

-

-

-

-

-

-

-

Pack size 1s

5 boxes

-

10 Vials

22.

ENOXIRT 0.5 g

IV injection

-

-

-

-

-

-

-

-

Pack size 1s

5 boxes

-

10 Vials

23.

ENOXIRT 1 g

IM

-

-

-

-

-

-

-

-

Pack size 1s

5 boxes

-

10 Vials

24.

ENOXIRT 1 g IV

injection

-

-

-

-

-

-

-

-

Pack size 1s

5 boxes

-

10 Vials

25.

ENOXIRT 1 g

IM/IV injection

-

-

-

-

-

-

-

-

Pack size 1s

5 boxes

Pack size 10s

1 box

-

10 Vials

26.

NEGACEF 2 g

IM/IV injection

-

-

-

-

-

-

-

-

Pack size 1s

5 boxes

Pack size 10s

1 box

-

10 Vials

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