7.3 Component Receipt, Storage & Material Transfer
Key Takeaways
On receipt, personnel check each lot's external packaging, labeling and condition, including temperature indicators. Unacceptable components are rejected, labeled as rejected, segregated, and other lots from that vendor are checked.
Components are stored closed, under their labeled temperature, humidity and light conditions. Storage temperature is monitored at least daily on open days (or continuously) and documented, and monitoring devices are verified every 12 months unless the manufacturer says otherwise.
Before items go onto the clean side of the anteroom, into a pass-through or into an SCA, gloved personnel wipe them with a sporicidal disinfectant, an EPA-registered disinfectant or sterile 70% IPA, allowing contact time or drying.
Just before entering the PEC, items are wiped with sterile 70% IPA, except that sterile items in sealed sterile packaging may be removed from the wrap as they are introduced.
Under USP <800>, antineoplastic HDs and HD APIs are unpacked in a neutral or negative-pressure area, never a sterile compounding or positive-pressure area. Those that need manipulation are stored separately in an externally vented, negative-pressure room with at least 12 air changes per hour.
7.3 Component Receipt, Storage & Material Transfer
Contamination often enters a cleanroom on things rather than people: a damaged vial, a carton dusted with spores, a warm refrigerated drug, or a bag wiped without enough contact time. The BCSCP outline covers component handling (task 1A5) from receipt through storage to transfer into the PEC. USP <797> Sections 8 and 9.3 set the rules, and USP <800> adds hazardous drug controls.
Receiving (USP <797> 9.3.2)
When each lot arrives, personnel:
- Examine the external packaging for damage and deterioration.
- Verify the labeling and condition, including whether the outer packaging is damaged and whether temperature-sensing indicators show exposure to excessive temperature.
- Reject unacceptable components promptly. They are clearly labeled as rejected and segregated from active stock until disposed of. Other lots from the same vendor are examined for the same defect.
- Mark the date of receipt on any API or added-substance package that has no vendor expiration date, and assign a conservative expiration date of no more than 1 year after receipt.
- Check supply chain status. Verify that the prescription drug came from an authorized trading partner with the required DSCSA transaction data, and quarantine suspect product (see 11.3).
Evaluation before use (9.3.3)
Before use, compounders confirm that every component has the correct identity and appropriate quality, is within its expiry, and has been stored properly. Packages are reinspected for breaks, loose caps or closures, and changes in appearance, aroma or texture. Sterile closures are reinspected for defects that could compromise sterility. Anything unacceptable is rejected, labeled and segregated, and other lots are checked.
Storage (9.3.4 and 19.1)
| Requirement | Detail |
|---|---|
| Containers | Closed, stored to prevent contamination, mix-ups and deterioration |
| Conditions | Temperature, humidity and light as the monograph or supplier specifies (USP <659> ranges) |
| Temperature monitoring | Manually at least once daily on days the facility is open, or with a continuous recorder |
| Records | A temperature log, or retrievable data in the continuous device |
| Device accuracy | Calibrated or verified as the manufacturer recommends, or every 12 months if unspecified |
| Excursions | Detected and minimized; affected items are evaluated before use |
Keep sterile compounding stock out of areas that generate particles. Store look-alike and sound-alike products apart. High-alert concentrates such as potassium chloride and hypertonic saline belong in segregated, labeled storage.
Moving materials into classified space (Section 8)
Into the SEC or SCA (8.1). Before any item goes onto the clean side of an anteroom, into a pass-through chamber, or into an SCA, it is wiped, if the packaging allows, with a sporicidal disinfectant, an EPA-registered disinfectant, or sterile 70% IPA. Low-lint wipers are used, and the person wiping wears gloves. An EPA-registered disinfectant or sporicidal must stay wet for its minimum contact time, and IPA must dry. Wiping must not damage the packaging or make the label unreadable.
Into the PEC (8.2). Just before an item enters the PEC, it is wiped with sterile 70% IPA on a sterile low-lint wiper and allowed to dry. Sterile items in sealed sterile packaging may be removed from the wrap as they go into the ISO Class 5 space, without wiping each item.
Critical sites (8.3). Vial stoppers, ampule necks and bag septums are wiped with sterile 70% IPA in the PEC and allowed to dry before they are punctured or opened.
Transport inside the facility. Carts must be cleanable, and a cart is not taken from the dirty side to the clean side unless the whole cart is cleaned. Materials that have been in patient care areas are not brought into anterooms, buffer rooms or SCAs unless thoroughly cleaned and disinfected.
Hazardous drug components (USP <800>)
| Step | USP <800> requirement |
|---|---|
| Unpacking | Antineoplastic HDs and all HD APIs are unpacked (removed from shipping containers) in a neutral/normal or negative-pressure area. Never in sterile compounding areas or positive-pressure areas |
| PPE at receipt | Chemotherapy gloves (ASTM D6978) when unpacking. A spill kit is available in the receiving area |
| Damaged shipments | Treated as spills and reported to the designated person. Opening them in a C-PEC is preferred. If only a sterile-compounding C-PEC is available, it must be deactivated, decontaminated, cleaned and disinfected before sterile work resumes |
| Storage | Antineoplastic HDs that need manipulation (other than counting or repackaging) and all HD APIs are stored separately from non-HDs, in an externally vented, negative-pressure room with at least 12 ACPH, and not on the floor |
| Refrigerated HDs | Kept in a dedicated refrigerator in a negative-pressure area with at least 12 ACPH (a storage room, buffer room or C-SCA) |
| Transport | Clearly labeled. Never sent through pneumatic tubes if liquid or antineoplastic |
| Wiping HD packaging | The solution used must not alter the product label |
HDs that return to the supplier wait in a designated negative-pressure area.
A refrigerated shipment of a vial product arrives with its temperature indicator showing exposure above the labeled range. What does USP <797> require?
Place it in the refrigerator and shorten its BUD by half
Reject it promptly, label it as rejected, segregate it from active stock, and examine other lots of that component from the same vendor for the same problem
Use it for Category 1 CSPs only
Wipe the vials with sterile 70% IPA and use them
Under USP <800>, where must a pharmacy store antineoplastic hazardous drugs that will be manipulated for sterile compounding?
On the open shelves of the general pharmacy, alphabetized with other drugs
Separately from non-HDs, in an externally vented, negative-pressure room with at least 12 air changes per hour
In the positive-pressure ISO Class 7 buffer room used for non-hazardous CSPs
On the floor of the receiving area until they are needed
A technician is loading sterile syringes that come in sealed sterile overwraps into an ISO Class 5 PEC. What does USP <797> allow?
The syringes may be removed from the sealed sterile wrap as they are introduced, without wiping each syringe
Each syringe must be taken out of the wrap in the anteroom and then wiped
The whole wrap must be sprayed with a sporicidal and left 10 minutes inside the PEC
Sterile supplies are exempt from every wiping and transfer rule
Sections you finish are checked off in the contents.